Clinical Trial: Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa.

This study has been completed.

Sponsors and Collaborators: Johns Hopkins Bloomberg School of Public Health
United States Agency for International Development (USAID)
Nelson R. Mandela School of Medicine, University of KwaZulu Natal, South Africa
Department of Paediatrics, Grey''''s Hospital, Pietermaritzburg, South Africa
Information provided by: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00138047

Purpose

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 Intervention Phase
HIV Infection
 Drug: zinc supplementation
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

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

Further Study Details: 
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
Expected Total Enrollment:  100

Study start: March 2003;  Study completion: August 2005
Last follow-up: September 2004;  Data entry closure: February 2005

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.

Eligibility

Ages Eligible for Study:  6 Months   -   60 Months,  Genders Eligible for Study:  Both
Criteria

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

Location Information


South Africa
      Grey''''s Hospital, PIETERMARITZBURG,  South Africa

Study chairs or principal investigators

William J Moss, MD, MPH,  Principal Investigator,  Johns Hopkins Bloomberg School of Public Health   
Robert E Black, MD, MPH,  Principal Investigator,  Johns Hopkins Bloomberg School of Public Health   
Raziya Bobat, MBChB, MD,  Principal Investigator,  Nelson R Mandela School of Medicine, University of KwaZulu-Natal   
Hoosen Coovadia, MD, MBBS,  Principal Investigator,  Doris Duke Medical Research Institute, University of KwaZulu-Natal   

More Information

Study ID Numbers:  H.22.02.03.25.B1
Last Updated:  August 29, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00138047
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30

Resources




Common Treatments

[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Follow Us