Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-11 @ 3:56 AM
Study NCT ID:
NCT03735303
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2018-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-16', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VD 3', 'timeFrame': '8 weeks', 'description': 'Serum level of 25-hydroxyvitamin D'}, {'measure': 'leptin', 'timeFrame': '8 weeks', 'description': 'serum level of leptin'}, {'measure': 'HbA1C', 'timeFrame': '8 weeks', 'description': 'plasma concentration of HbA1C'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin D3', 'vitamin D deficiency', 'leptin', 'A1C', 'omega-3 fatty acid'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '21492489', 'type': 'RESULT', 'citation': 'Ross AC. The 2011 report on dietary reference intakes for calcium and vitamin D. Public Health Nutr. 2011 May;14(5):938-9. doi: 10.1017/S1368980011000565. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.', 'detailedDescription': 'Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)\n\nThis study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.\n\nThis randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on serum leptin and Glycated hemoglobin (Hb A1C) levels .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* jordanian people aged 25-55\n* medical diagnosis of vitamin D deficiency ( VD \\<25 ng/ ml)\n\nExclusion Criteria:\n\n* Blood disorders including\n* thalassemia\n* sickle cell disease'}, 'identificationModule': {'nctId': 'NCT03735303', 'briefTitle': 'Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Applied Science Private University'}, 'officialTitle': 'The Combined Effect of Vitamin D3 and Omega-3 Supplements on Serum Leptin and Glycated Hemoglobin (Hb A1C) Levels in Jordanian People With Vitamin D Deficiency.', 'orgStudyIdInfo': {'id': 'DRGS-4-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VD3 group', 'description': 'dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks', 'interventionNames': ['Dietary Supplement: VD3 group']}, {'type': 'EXPERIMENTAL', 'label': 'omega 3- FA group', 'description': 'dietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks', 'interventionNames': ['Dietary Supplement: omega 3 FA group']}, {'type': 'EXPERIMENTAL', 'label': 'VD3 and omega 3 FA group', 'description': 'dietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks', 'interventionNames': ['Dietary Supplement: VD3 and omega- 3FA group']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'no intervention was given', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'VD3 group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'VD3 50000 IU/ week for 8 weeks', 'armGroupLabels': ['VD3 group']}, {'name': 'omega 3 FA group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'omega 3 FA group 300 mg once daily for 8 weeks', 'armGroupLabels': ['omega 3- FA group']}, {'name': 'VD3 and omega- 3FA group', 'type': 'DIETARY_SUPPLEMENT', 'description': '50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks', 'armGroupLabels': ['VD3 and omega 3 FA group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'no intervention was given', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11931', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Applied Science University', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Mahmoud S Abu-Samak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Applied Science Private University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'when summary data will published', 'ipdSharing': 'YES', 'description': 'all IPD that underline results in a publication', 'accessCriteria': 'open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Applied Science Private University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}