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Completed

NCT Number: NCT00138047

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

6 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Grey's Hospital

Pietermaritzburg, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc Supplementation

Drug

Primary outcomes

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

Secondary outcomes

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

  2. number of illness visits

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Grey's Hospital
  • United States Agency for International Development (USAID)
  • University of KwaZulu

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children

Important dates

Study start
2003
Study completion
2004
First posted
Aug 30, 2005
Registry last updated
Dec 5, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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