Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
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ClinicalTrials.gov Identifier: NCT00138047
Recruitment Status :
First Posted : August 30, 2005
Last Update Posted : December 5, 2005
Johns Hopkins Bloomberg School of Public Health
United States Agency for International Development (USAID)
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.
Condition or disease
Drug: zinc supplementation
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.
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