Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
Status and phase
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Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
Inclusion criteria
- HIV-infection
- 6 to 60 months of age
- Not receiving antiretroviral therapy
- Cared for as outpatients at Grey's Hospital
Exclusion criteria
- Receiving antiretroviral therapy
Trial design
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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