HIV Infections
Conditions
Keywords
zinc, HIV, children
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.
Interventions
Sponsors
United States Agency for International Development (USAID)
University of KwaZulu
Grey's Hospital
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Months to 60 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean difference in log10 HIV-1 viral load at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| mean difference in percentage of CD4+ T-cells at each visit | — |
| number of illness visits | — |
Countries
South Africa
Outcome results
None listed