Botswana Vitamin D Supplementation Study in HIV/AIDS

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).

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Dietary supplement: 4000 IU/d D3 over 12 weeks; Dietary supplement: 7000 IU/d D3 over 12 weeks

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Botswana
  • Gaborone, Botswana, 0000
    • Princess Marina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 51 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Dietary supplement: 7000 IU/d D3 over 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	12 weeks
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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Vitamin D
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 812323