Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-02-01 @ 9:17 PM
Study NCT ID:
NCT02189902
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botswana Vitamin D Supplementation Study in HIV/AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-14', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test the efficacy of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to replete vit D status (achieving a minimum serum 25D concentration of 32 ng/mL).', 'timeFrame': '12 weeks', 'description': 'To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL.'}, {'measure': 'To test the safety of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS as determined by serum calcium.', 'timeFrame': '12 weeks', 'description': 'To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess safety as determined by serum calcium.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '25706751', 'type': 'DERIVED', 'citation': 'Steenhoff AP, Schall JI, Samuel J, Seme B, Marape M, Ratshaa B, Goercke I, Tolle M, Nnyepi MS, Mazhani L, Zemel BS, Rutstein RM, Stallings VA. Vitamin D(3)supplementation in Batswana children and adults with HIV: a pilot double blind randomized controlled trial. PLoS One. 2015 Feb 23;10(2):e0117123. doi: 10.1371/journal.pone.0117123. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The goal is to determine the vit D supplementation dose that safely results in optimal serum vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).', 'detailedDescription': 'Many people living with HIV/AIDS in African countries are vit D deficient or insufficient. Vit D deficiency in HIV/AIDS may be due to low dietary vit D intake, increased requirements, malabsorption, specific drug therapies (antiretrovirals, in particular), reduced outdoor physical activity, reduced vit D synthesis from UV light exposure in dark skin pigmented individuals, or unknown HIV-associated factors. Vit D deficiency likely contributes to abnormal immune status and increased inflammatory state, and to poor growth, bone, and muscle function, and may contribute to risk for tuberculosis (TB) infection. The goal is to determine the vit D supplementation dose that safely results in optimal serum 25D concentrations in HIV-infected children and adults living in Botswana.\n\nTo do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '51 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infection\n* Ages 5.0 to 50.9 y\n* In usual state of good health\n* Subject and/or family commitment to the 12-week study\n\nExclusion Criteria:\n\n* Other chronic health conditions unrelated to HIV/AIDS that may affect nutritional status\n* Use of vit D supplementation above 400 IU/d'}, 'identificationModule': {'nctId': 'NCT02189902', 'briefTitle': 'Botswana Vitamin D Supplementation Study in HIV/AIDS', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Botswana Vitamin D Supplementation Study in HIV/AIDS', 'orgStudyIdInfo': {'id': '812323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '4000 IU/d of D3 by mouth for 12 weeks', 'description': '4000 IU/d of D3 by mouth for 12 weeks', 'interventionNames': ['Dietary Supplement: 4000 IU/d D3 over 12 weeks']}, {'type': 'EXPERIMENTAL', 'label': '7000IU/d of D3 by mouth for 12 weeks', 'description': '7000IU/d of D3 by mouth for 12 weeks', 'interventionNames': ['Dietary Supplement: 7000 IU/d D3 over 12 weeks']}], 'interventions': [{'name': '4000 IU/d D3 over 12 weeks', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['4000 IU/d of D3 by mouth for 12 weeks']}, {'name': '7000 IU/d D3 over 12 weeks', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['7000IU/d of D3 by mouth for 12 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Princess Marina Hospital', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}], 'overallOfficials': [{'name': 'Virginia Stallings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Virginia Stallings', 'investigatorAffiliation': "Children's Hospital of Philadelphia"}}}}