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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00138047
First Posted: August 30, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
United States Agency for International Development (USAID)
University of KwaZulu
Grey's Hospital
Information provided by:
Johns Hopkins Bloomberg School of Public Health
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00138047     History of Changes
Other Study ID Numbers: H.22.02.03.25.B1
First Submitted: August 26, 2005
First Posted: August 30, 2005
Last Update Posted: December 9, 2005
Last Verified: August 2005

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
zinc
HIV
children

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs