Botswana Vitamin D Supplementation Study in HIV/AIDS

• ClinicalTrials.gov Identifier: NCT02189902
• Recruitment Status: Completed
• First Posted: July 15, 2014
• Last Update Posted: July 15, 2014
• Sponsor: Children's Hospital of Philadelphia
• Information provided by (Responsible Party): Virginia Stallings, Children's Hospital of Philadelphia

Study Description

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Botswana

Princess Marina Hospital

Gaborone, Botswana, 0000

Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators

• Principal Investigator: Virginia Stallings, MD; Children's Hospital of Philadelphia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 D₃supplementation 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.

• 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
• 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:

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