Viewing Study NCT03686150

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Ignite Creation Date: 2025-12-24 @ 4:45 PM
Ignite Modification Date: 2026-01-08 @ 3:47 AM
Study NCT ID: NCT03686150
Status: COMPLETED
Last Update Posted: 2023-04-19
First Post: 2018-09-25
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Vitamin D Oral Replacement in Asthma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stounpraseuth@uams.edu', 'phone': '501-686-7233', 'title': 'Songthip Ounpraseuth', 'organization': 'University of Arkansas for Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period)', 'description': 'Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1, Cohort 1 Vitamin D3 Oral Regimen', 'description': 'Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1, Cohort 2 Vitamin D3 Oral Regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part 1, Cohort 3 Vitamin D3 Oral Regimen', 'description': 'Vitamin D: 6000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part 1, Cohort 4 Vitamin D3 Oral Regimen', 'description': 'Vitamin D: 600 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part 2, Cohort A Vitamin D3 Oral Regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 21, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 2, Cohort B Vitamin D Oral Regimen', 'description': 'Vitamin D: 600 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 14, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'adenoidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'adenotonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'amebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'animal scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'chest cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'dyspnoea', 'stats': 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0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'wisdom teeth removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Asthma', 'notes': 'In all cases, this SAE was not related to Vitamin D or study procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Anaphylactic Reaction', 'notes': 'This SAE was not related to Vitamin D or study procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Optimal Dosing Level to Use in Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}, {'units': 'Serum Concentrations', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 Oral Regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}], 'classes': [{'title': 'Daily Dose (IU)', 'categories': [{'measurements': [{'value': '8000', 'groupId': 'OG000'}]}]}, {'title': 'Single Loading Dose (IU)', 'categories': [{'measurements': [{'value': '50000', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'Part 1 of this study was to perform a population PK analysis of 25(OH)D after oral administration of Vitamin D in children who are overweight or obese and have asthma. Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a population PK analysis of 25(OH)D after oral administration of Vitamin D.', 'otherAnalysisDescription': 'Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.'}], 'paramType': 'NUMBER', 'timeFrame': '20 weeks', 'description': 'Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.', 'unitOfMeasure': 'IU', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Serum Concentrations', 'denomUnitsSelected': 'Serum Concentrations', 'populationDescription': 'A total of 263 PK samples from 48 participants were collected in part 1 of the VDORA1 study. For the population PK analysis, 36 samples with missing prior dosing information from 13 participants were excluded, leaving a final analysis population of 44 participants with 227 serum concentrations.'}, {'type': 'PRIMARY', 'title': 'Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2, Cohort A Vitamin D3 Oral Regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'OG001', 'title': 'Part 2, Cohort B Vitamin D Oral Regimen', 'description': 'Vitamin D: 600 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.786', 'groupId': 'OG000', 'lowerLimit': '0.641', 'upperLimit': '0.883'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.176'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'groupDescription': 'This is a one-sample test of proportion.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This is one-sample test of proportion testing the null hypothesis that the proportion of participants with 25(OH)D level \\>= 40 ng/mL is 50%.'}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'Proportion of participants in part 2 who achieve vitamin levels \\>= 40 ng/ml', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from Cohort A and three participants from Cohort B did not have 25(OH)D measurements at Visit 6 (week 16).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1, Cohort 1 Vitamin D3 Oral Regimen', 'description': 'Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'FG001', 'title': 'Part 1, Cohort 2 Vitamin D3 Oral Regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'FG002', 'title': 'Part 1, Cohort 3 Vitamin D3 Oral Regimen', 'description': 'Vitamin D: 6000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'FG003', 'title': 'Part 1, Cohort 4 Vitamin D3 Oral Regimen', 'description': 'Vitamin D: 600 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'FG004', 'title': 'Part 2, Cohort A Vitamin D3 Oral Regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'FG005', 'title': 'Part 2, Cohort B Vitamin D Oral Regimen', 'description': 'Vitamin D: 600 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '42'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 166 study participants consented to be screened for the trial; 112 met eligibility criteria and were randomized onto the trial.\n\nThe trial comprised of a Dose Finding part (Part 1) and a Dose Confirming par (Part 2). During Part 1, participants (children) were enrolled and randomized to one of four dose groups at 1:1:1:1 allocation ratio. During Part 2, participants (children) were randomized to one of two dose groups at 2:1 allocation ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1, Cohort 1 Vitamin D3 Oral Regimen', 'description': 'Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'BG001', 'title': 'Part 1, Cohort 2 Vitamin D3 Oral Regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'BG002', 'title': 'Part 1, Cohort 3 Vitamin D3 Oral Regimen', 'description': 'Vitamin D: 6000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'BG003', 'title': 'Part 1, Cohort 4 Vitamin D3 Oral Regimen', 'description': 'Vitamin D: 600 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'BG004', 'title': 'Part 2, Cohort A Vitamin D3 Oral Regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'BG005', 'title': 'Part 2, Cohort B Vitamin D Oral Regimen', 'description': 'Vitamin D: 600 IU daily dose\n\nVitamin D3 oral regimen: Vitamin D3 oral regimens supplementation'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '12.3', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '11.5', 'spread': '3.6', 'groupId': 'BG002'}, {'value': '12.5', 'spread': '2.9', 'groupId': 'BG003'}, {'value': '12.2', 'spread': '2.5', 'groupId': 'BG004'}, {'value': '11.7', 'spread': '2.6', 'groupId': 'BG005'}, {'value': '12.1', 'spread': '2.8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '86', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '46', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '33.9', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '30.1', 'spread': '4.3', 'groupId': 'BG002'}, {'value': '32.2', 'spread': '9.2', 'groupId': 'BG003'}, {'value': '30.8', 'spread': '6.9', 'groupId': 'BG004'}, {'value': '30.3', 'spread': '8.2', 'groupId': 'BG005'}, {'value': '31.0', 'spread': '7.3', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI percentile', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}], 'categories': [{'title': '>= 85th to < 95th', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}, {'title': '>= 95th to < 99th', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}, {'title': '>= 99th', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '52', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Rural-Urban Commuting Area (RUCA) codes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Metropolitan', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '92', 'groupId': 'BG006'}]}, {'title': 'Micropolitan', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'Small town', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'Rural', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The RUCA codes classify US census tract based on measures of urbanization, population density, and daily commuting from the decennial census. The classification contains whole numbers (1-10) used to delineate metropolitan (1-3), micropolitan (4-6), small town (7-9), and rural areas (10).', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline 25(OH)D', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '109', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '18.3', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '20.8', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '19.0', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '17.6', 'spread': '5.8', 'groupId': 'BG003'}, {'value': '17.7', 'spread': '6.0', 'groupId': 'BG004'}, {'value': '16.3', 'spread': '5.2', 'groupId': 'BG005'}, {'value': '18.0', 'spread': '6.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': '25(OH)D = (25-hydroxy vitamin D); Baseline measures were captured at visit 2 (day 0; week 1).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.'}, {'title': 'Baseline 25(OH)D level > 100 ng/mL', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '109', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '109', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '25(OH)D = (25-hydroxy vitamin D)', 'unitOfMeasure': 'Participants', 'populationDescription': 'Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.'}], 'populationDescription': 'This vitamin D supplementation study was performed in two parts: 1) PK analysis to identify recommended dost for part 2, and 2) assess the effectiveness of the recommended 16-week dosing regimen to achieve serum level of 25(OH)D greater than or equal to 40 ng/mL.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-14', 'size': 960734, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-06T10:49', 'hasProtocol': True}, {'date': '2020-11-02', 'size': 1074943, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-03-24T10:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2018-09-25', 'resultsFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-27', 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Optimal Dosing Level to Use in Part 2', 'timeFrame': '20 weeks', 'description': 'Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.'}, {'measure': 'Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml', 'timeFrame': '16 weeks', 'description': 'Proportion of participants in part 2 who achieve vitamin levels \\>= 40 ng/ml'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric obesity'], 'conditions': ['Asthma', 'Vitamin D Deficiency', 'Pediatric Obesity']}, 'referencesModule': {'references': [{'pmid': '32930511', 'type': 'BACKGROUND', 'citation': "O'Sullivan BP, James L, Majure JM, Bickel S, Phan LT, Serrano Gonzalez M, Staples H, Tam-Williams J, Lang J, Snowden J; IDeA States Pediatric Clinical Trials Network. Obesity-related asthma in children: A role for vitamin D. Pediatr Pulmonol. 2021 Feb;56(2):354-361. doi: 10.1002/ppul.25053. Epub 2020 Dec 8."}, {'pmid': '37646988', 'type': 'DERIVED', 'citation': "Lang JE, Ramirez RG, Balevic S, Bickel S, Hornik CP, Majure JM, Venkatachalam S, Snowden J, O'Sullivan B, James L. Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma. Clin Pharmacokinet. 2023 Nov;62(11):1567-1579. doi: 10.1007/s40262-023-01285-9. Epub 2023 Aug 30."}]}, 'descriptionModule': {'briefSummary': 'The overall objective of the study is to determine the pharmacokinetics of Vitamin D supplementation in children who have asthma and are overweight or obese.', 'detailedDescription': 'This study has two parts. In part 1, study participants will be randomized to receive one of four doses of vitamin D supplementation in international units (IU) over at 16-week period: 1) Single 50,000 IU loading dose + 6000 IU daily dose; 2) Single 50,000 IU loading dose + 10,000 IU daily dose: 3) 6000 IU daily dose; or 4) 600 IU daily dose. Based on pharmacokinetic analysis, one of the doses (1-3) will be selected to use in part 2.\n\nIn part 2, study participants will be randomized to the dose selected in part 1 or the 600 IU daily dose of vitamin D supplementation to be administered over a 16-week dosing period.\n\nAcross both parts, safety of each dose regimen of vitamin D supplementation will be evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater than or equal to 40 ng/ml will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index greater than or equal to 85% for age and sex\n* Physician-diagnosed asthma\n* Ongoing relationship with asthma provider responsible for asthma care\n* Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test\n* Ability to swallow pills similar in size to the vitamin D preparation to be used\n* Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate)\n* Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method\n* Child and parent, legal guardian, or caregiver must speak English or Spanish\n\nExclusion Criteria:\n\n* Known diseases of calcium metabolism or the parathyroid\n* History of renal insufficiency or kidney stones\n* Known liver failure or history of abnormal liver function tests\n* History of Williams syndrome, sarcoidosis, or granulomatous disease\n* Active tuberculosis\n* Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration\n* Clinical evidence of rickets\n* Taking supplemental vitamin D greater than equal to 1000 IU per day'}, 'identificationModule': {'nctId': 'NCT03686150', 'acronym': 'VDORA1', 'briefTitle': 'Vitamin D Oral Replacement in Asthma', 'organization': {'class': 'NETWORK', 'fullName': 'IDeA States Pediatric Clinical Trials Network'}, 'officialTitle': 'Vitamin D Oral Replacement in Asthma', 'orgStudyIdInfo': {'id': '101'}, 'secondaryIdInfos': [{'id': 'U24OD024957', 'link': 'https://reporter.nih.gov/quickSearch/U24OD024957', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 1 Vitamin D3 oral regimen', 'description': 'Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose', 'interventionNames': ['Dietary Supplement: Vitamin D3 oral regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 2 Vitamin D3 oral regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose', 'interventionNames': ['Dietary Supplement: Vitamin D3 oral regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 3 Vitamin D3 oral regimen', 'description': 'Vitamin D: 6000 IU daily dose', 'interventionNames': ['Dietary Supplement: Vitamin D3 oral regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 1, Cohort 4 Vitamin D3 oral regimen', 'description': 'Vitamin D: 600 IU daily dose', 'interventionNames': ['Dietary Supplement: Vitamin D3 oral regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Cohort A Vitamin D3 oral regimen', 'description': 'Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD', 'interventionNames': ['Dietary Supplement: Vitamin D3 oral regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2, Cohort B Vitamin D oral regimen', 'description': 'Vitamin D: 600 IU daily dose', 'interventionNames': ['Dietary Supplement: Vitamin D3 oral regimen']}], 'interventions': [{'name': 'Vitamin D3 oral regimen', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin D3 oral regimens supplementation', 'armGroupLabels': ['Part 1, Cohort 1 Vitamin D3 oral regimen', 'Part 1, Cohort 2 Vitamin D3 oral regimen', 'Part 1, Cohort 3 Vitamin D3 oral regimen', 'Part 1, Cohort 4 Vitamin D3 oral regimen', 'Part 2, Cohort A Vitamin D3 oral regimen', 'Part 2, Cohort B Vitamin D oral regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours/Alfred I duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '96826', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kapiolani Medical Center for Women and Children', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '40292', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '59804', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Community Medical Center', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': "University of Nebraska Medical Center/Children's Hospital and Medical Center", 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '03104', 'city': 'Manchester', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hospital - Manchester', 'geoPoint': {'lat': 42.99564, 'lon': -71.45479}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "Children's Hospital OU Medical Center", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont Medical Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Anticipated date of data upload is September 2023', 'ipdSharing': 'YES', 'description': 'Data will be uploaded to Data and Specimen Hub (DASH) of NICHD', 'accessCriteria': 'per DASH requirements'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IDeA States Pediatric Clinical Trials Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}