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

This study has been completed.

First Received: August 26, 2005 Last Updated: December 2, 2005 History of Changes

Sponsors and Collaborators:	Johns Hopkins Bloomberg School of Public Health United States Agency for International Development (USAID) University of KwaZulu Grey's Hospital
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 Infections	Drug: zinc supplementation	Phase II

MedlinePlus related topics: AIDS Dietary Supplements

U.S. FDA Resources

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 as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	March 2003
Estimated Study Completion Date:	September 2004

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.

Eligibility

Ages Eligible for Study:	6 Months to 60 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138047

Locations

South Africa
Grey's Hospital
Pietermaritzburg, South Africa

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

United States Agency for International Development (USAID)

University of KwaZulu

Grey's Hospital

Investigators

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

More Information

No publications provided

Study ID Numbers:	H.22.02.03.25.B1
Study First Received:	August 26, 2005
Last Updated:	December 2, 2005
ClinicalTrials.gov Identifier:	NCT00138047 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

zinc
HIV
children

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Zinc
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Trace Elements
Micronutrients
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Growth Substances
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Trace Elements
Infection

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Zinc
Lentivirus Infections
Micronutrients
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009