Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT02044133
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yves.bleher@ght85.fr', 'phone': '0251446572', 'title': 'Dr Yves BLEHER', 'organization': 'Centre hospitalier départemental Vendée'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The planned follow-up period for patients is six months until the M6 visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Dosage of Vitamine D : Inclusion and 6 Month', 'description': 'Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry\n\nDosage Vitamine D', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dosage of Vitamine D 6 Month', 'description': 'Participant will have one dosage of vitamine D 6 month after entry to prison\n\nDosage Vitamine D', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dosage of Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dosage of Vitamine D : Inclusion and 6 Month', 'description': 'Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry\n\nDosage Vitamine D'}, {'id': 'OG001', 'title': 'Dosage of Vitamine D 6 Month', 'description': 'Participant will have one dosage of vitamine D 6 month after entry to prison\n\nDosage Vitamine D'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Vitamin D level in ng/mL', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analyse'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dosage of Vitamine D : Inclusion and 6 Month', 'description': 'Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry\n\nDosage Vitamine D'}, {'id': 'FG001', 'title': 'Dosage of Vitamine D 6 Month', 'description': 'Participant will have one dosage of vitamine D 6 month after entry to prison\n\nDosage Vitamine D'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Release', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Transfer', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'refusal of blood sampling', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruted based on physicien referral between september 2013 and january 2016. The first participant was enrolled on january 29, 2014 and the last participant was enrolled in july 15, 2015. 54 patients met inclusion criteria and were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dosage of Vitamine D : Inclusion and 6 Month', 'description': 'Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry\n\nDosage Vitamine D'}, {'id': 'BG001', 'title': 'Dosage of Vitamine D 6 Month', 'description': 'Participant will have one dosage of vitamine D 6 month after entry to prison\n\nDosage Vitamine D'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.6', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '35.3', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '32.5', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2014-01-21', 'resultsFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-25', 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosage of Vitamin D', 'timeFrame': '6 month', 'description': 'Vitamin D level in ng/mL'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Male Prisoner']}, 'descriptionModule': {'briefSummary': 'The study will be proposed to man entering the prison of La Roche sur Yon. Participants will be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6 months after the entry and the second arm will carry only a dosage six months after entry.\n\nthe purpose of the study is to determine the interest of dosage of vitamin D in biological assessment of entry into prison house.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Incarcerated person\n* Imprisoned in La Roche sur Yon\n* Male\n* Age \\> 18 year old\n* Not opposed to participation in the study\n\nExclusion Criteria:\n\n* Intellectual deficit not to understand the study\n* Taking osteoporosis treatment or any other affecting the metabolism of vitamin D\n* Renal failure, liver failure\n* Hypercalcemia\n* Thyroid dysfunction, parathyroid diseases\n* Duration of imprisonment less than the expected duration of the study.\n* Incarcerated person who had received supplementation of vitamin D in the 6 months prior'}, 'identificationModule': {'nctId': 'NCT02044133', 'briefTitle': 'Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)', 'orgStudyIdInfo': {'id': 'CHD026-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dosage of vitamine D : inclusion and 6 month', 'description': 'Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry', 'interventionNames': ['Other: Dosage Vitamine D']}, {'type': 'OTHER', 'label': 'Dosage of Vitamine D 6 month', 'description': 'Participant will have one dosage of vitamine D 6 month after entry to prison', 'interventionNames': ['Other: Dosage Vitamine D']}], 'interventions': [{'name': 'Dosage Vitamine D', 'type': 'OTHER', 'armGroupLabels': ['Dosage of Vitamine D 6 month', 'Dosage of vitamine D : inclusion and 6 month']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre hospitalier départemental Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}], 'overallOfficials': [{'name': 'Yves BLEHER, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHD Vendée La Roche sur Yon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}