Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-09 @ 1:28 PM
Study NCT ID:
NCT02822651
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypovitaminosis D Prediction Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2592}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '25 (OH) vitamin D blood concentration', 'timeFrame': 'The day of inclusion', 'description': 'Vitamin D determination will be carried out for each center in a single laboratory by chemiluminescence technique.\n\nVitamin D determination is the gold standard for the development and validation phases of the score. It will define the variables of the self-administered questionnaire to be included in the final score (development phase) and be the gold standard in the evaluation of the performance score (validation phase). The blood sample will be collected after the completion of the questionnaire, on the same day.'}], 'secondaryOutcomes': [{'measure': 'Vitamin D concentration level', 'timeFrame': 'The day of inclusion', 'description': 'The ability of the score to classify adults in one of these three categories:\n\n* Category 1 : Vitamin D sufficiency (≥30 ng/ml)\n* Category 2 : Hypovitaminosis D between 30 and 10 ng/ml\n\n * Vitamin D insufficiency (\\<30 ng/ml)\n * Vitamin D deficiency (\\<20 ng/ml)\n* Category 3 : Severe deficiency (\\<10 ng/ml)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vitamin D Status']}, 'referencesModule': {'references': [{'pmid': '34444687', 'type': 'RESULT', 'citation': 'Viprey M, Merle B, Riche B, Freyssenge J, Rippert P, Chakir MA, Thomas T, Malochet-Guinamand S, Cortet B, Breuil V, Chapurlat R, Lafage Proust MH, Carlier MC, Fassier JB, Haesebaert J, Caillet P, Rabilloud M, Schott AM. Development and Validation of a Predictive Model of Hypovitaminosis D in General Adult Population: SCOPYD Study. Nutrients. 2021 Jul 23;13(8):2526. doi: 10.3390/nu13082526.'}]}, 'descriptionModule': {'briefSummary': 'Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (\\<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (\\<20ng/ml) and 5% with severe deficiency (\\<10ng/ml).\n\nBecause of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5 million € in 2011, and with it the costs for health insurance. However, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.\n\nWe propose to develop a predictive clinical score of hypovitaminosis D based on the accurate assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected through a self-administered questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Men and women aged 18 to 70 years old\n\nExclusion Criteria:\n\n* Participation in a study related to vitamin D\n* Taking at least 80 000 IU vitamin D in the last 3 months as a single dose\n* Pregnancy or breast-feeding\n* Renal failure : severe renal impairment, dialysis, having kidney transplant\n* Known hepatic impairment\n* Gastrointestinal disorders: Celiac disease, Crohn's disease, ulcerative colitis, bariatric surgery, gastrointestinal surgery with stoma\n* Known primary hypo/hyperparathyroidism\n* Bone cancer/metastases current or in the last 2 years\n* Treatment with antiepileptics\n* Long-term treatment with glucocorticoids (\\> 3 months)\n* Treatment with antiretroviral\n* Legal incapacity or limited legal capacity\n* Non-recipient of French Social Security"}, 'identificationModule': {'nctId': 'NCT02822651', 'acronym': 'SCOPYD', 'briefTitle': 'Hypovitaminosis D Prediction Score', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D', 'orgStudyIdInfo': {'id': '69HCL15_0078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D status', 'description': 'The 2500 subjects included in this unique arm will complete a self-administered questionnaire and will have a blood sampling to measure vitamin D blood concentration.', 'interventionNames': ['Biological: Blood sampling', 'Other: self-administered questionnaire']}], 'interventions': [{'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': 'Patients will have a blood sampling at inclusion to measure vitamin D blood concentration.', 'armGroupLabels': ['Vitamin D status']}, {'name': 'self-administered questionnaire', 'type': 'OTHER', 'description': 'Patients will fill a self-administered questionnaire the day of inclusion', 'armGroupLabels': ['Vitamin D status']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69424', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Pôle IMER', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Anne-Marie SCHOTT-PETHELAZ, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}