A Phase 2 interventional study of zinc supplementation in HIV Infections, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in South Africa. Open to participants aged 6 Months to 60 Months. Per ClinicalTrials.gov, last updated 2005-12-05.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 2, Interventional, and Treatment
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 100 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
mean difference in log10 HIV-1 viral load at each visit
mean difference in percentage of CD4+ T-cells at each visit
number of illness visits
This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health