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Botswana Vitamin D Supplementation Study in HIV/AIDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189902
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Virginia Stallings, Children's Hospital of Philadelphia

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
HIV Dietary Supplement: 4000 IU/d D3 over 12 weeks Dietary Supplement: 7000 IU/d D3 over 12 weeks Phase 3

Detailed Description:

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.

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botswana Vitamin D Supplementation Study in HIV/AIDS
Study Start Date : January 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: 4000 IU/d of D3 by mouth for 12 weeks
4000 IU/d of D3 by mouth for 12 weeks
Dietary Supplement: 4000 IU/d D3 over 12 weeks
Experimental: 7000IU/d of D3 by mouth for 12 weeks
7000IU/d of D3 by mouth for 12 weeks
Dietary Supplement: 7000 IU/d D3 over 12 weeks



Primary Outcome Measures :
  1. 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). [ Time Frame: 12 weeks ]
    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.

  2. 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. [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 51 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infection
  • Ages 5.0 to 50.9 y
  • In usual state of good health
  • Subject and/or family commitment to the 12-week study

Exclusion Criteria:

  • Other chronic health conditions unrelated to HIV/AIDS that may affect nutritional status
  • Use of vit D supplementation above 400 IU/d

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189902


Locations
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Botswana
Princess Marina Hospital
Gaborone, Botswana, 0000
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Virginia Stallings, MD Children's Hospital of Philadelphia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virginia Stallings, Professor of Pediatrics, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02189902    
Other Study ID Numbers: 812323
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014
Keywords provided by Virginia Stallings, Children's Hospital of Philadelphia:
Vitamin D
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases