Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
- Conditions
- HIV Infections
- Registration Number
- NCT00138047
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief Summary
The goal of the study is to rule out a harmful effect of zinc supplementation in HIV-1-infected children. The null hypothesis is that zinc supplementation will increase plasma HIV RNA levels.
- Detailed Description
A randomized, double-blind, placebo-controlled equivalence trial of zinc supplementation was conducted at Grey's Hospital in Pietermaritzburg, South Africa. Ninety-six HIV-1-infected children were randomly assigned to receive 10 mg of elemental zinc as sulfate or placebo daily for 6 months. Baseline measurements of plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were established at two study visits prior to randomization, and measurements were repeated 3, 6 and 9 months after starting supplementation. Plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were compared before and after supplementation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- HIV-infection
- 6 to 60 months of age
- Not receiving antiretroviral therapy
- Cared for as outpatients at Grey's Hospital
- Receiving antiretroviral therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method mean difference in log10 HIV-1 viral load at each visit
- Secondary Outcome Measures
Name Time Method mean difference in percentage of CD4+ T-cells at each visit number of illness visits
Trial Locations
- Locations (1)
Grey's Hospital
🇿🇦Pietermaritzburg, South Africa