Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-27 @ 5:01 AM
Study NCT ID:
NCT02975492
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-07', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from calcium level in urines at day 7, day 14 and day 28', 'timeFrame': 'day 7, day 14 and day 28'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transient Hypercalciuria']}, 'descriptionModule': {'briefSummary': 'Recommendations for vitamin D supplementation for subjets between 2 and 18 years offer strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months. Data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training Randall plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin D, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 2 to 17 years included\n* Obtaining informed consent of the parents signed\n* Participants aged 18 years included'}, 'identificationModule': {'nctId': 'NCT02975492', 'acronym': 'DonneDVit', 'briefTitle': 'Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': "Evaluation de l'Impact d'un Mode de supplémentation en Vitamine D (Dose séquentielle vs Dose Quotidienne) Sur l'Incidence de l'Hypercalciurie Chez Des Sujets Des départements du Gard et de l'Hérault agés de 2 à 18 Ans. Etude contrôlée randomisée en 2 Groupes parallèles", 'orgStudyIdInfo': {'id': 'RECHMPL15_0500'}, 'secondaryIdInfos': [{'id': 'UF 9676', 'type': 'OTHER', 'domain': 'Montpellier University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cholecalciferol sequential dose', 'description': 'cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)', 'interventionNames': ['Drug: Cholecalciferol sequential dose']}, {'type': 'EXPERIMENTAL', 'label': 'Cholecalciferol daily dose', 'description': 'cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day)', 'interventionNames': ['Drug: Cholecalciferol daily dose']}], 'interventions': [{'name': 'Cholecalciferol sequential dose', 'type': 'DRUG', 'otherNames': ['Vitamin D'], 'description': 'sequential dose administration of the treatment', 'armGroupLabels': ['Cholecalciferol sequential dose']}, {'name': 'Cholecalciferol daily dose', 'type': 'DRUG', 'otherNames': ['Vitamin D'], 'description': 'daily dose administration of the treatment', 'armGroupLabels': ['Cholecalciferol daily dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Denis MORIN, MD', 'role': 'CONTACT'}], 'facility': 'Pediatric department', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tu-Anh TRAN, MD', 'role': 'CONTACT', 'phone': '04 66 68 32 84'}], 'facility': 'Pediatric department', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'centralContacts': [{'name': 'Denis MORIN, MD', 'role': 'CONTACT', 'email': 'd-morin@chu-montpellier.fr', 'phone': '0467336607'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}