Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa

Johns Hopkins Bloomberg School of Public Health100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

HIV Infections

Interventions

zinc supplementationDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 60 Months

Medical Language ↔ Plain English

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

Locations (1)

Grey's Hospital

Pietermaritzburg, South Africa

Outcomes

Primary Outcomes

mean difference in log10 HIV-1 viral load at each visit

Secondary Outcomes

mean difference in percentage of CD4+ T-cells at each visit

number of illness visits

Data from ClinicalTrials.gov

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