Back to resultsSafety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
zinc supplementation
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring zinc, HIV, children
Eligibility 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
Sites / Locations
- Grey's Hospital
Outcomes
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
Full Information
NCT ID
NCT00138047
First Posted
August 26, 2005
Last Updated
December 2, 2005
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
United States Agency for International Development (USAID), University of KwaZulu, Grey's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00138047
Brief Title
Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
Official Title
Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
United States Agency for International Development (USAID), University of KwaZulu, Grey's Hospital
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
zinc, HIV, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
zinc supplementation
Primary Outcome Measure Information:
Title
mean difference in log10 HIV-1 viral load at each visit
Secondary Outcome Measure Information:
Title
mean difference in percentage of CD4+ T-cells at each visit
Title
number of illness visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J Moss, MD, MPH
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert E Black, MD, MPH
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raziya Bobat, MBChB, MD
Organizational Affiliation
Nelson R Mandela School of Medicine, University of KwaZulu-Natal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hoosen Coovadia, MD, MBBS
Organizational Affiliation
Doris Duke Medical Research Institute, University of KwaZulu-Natal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grey's Hospital
City
Pietermaritzburg
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
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