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

NCT ID: NCT00138047

Last Updated: 2005-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-09-30

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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zinc HIV children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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zinc supplementation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

University of KwaZulu

OTHER

Sponsor Role collaborator

Grey's Hospital

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Principal Investigators

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William J Moss, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Robert E Black, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Raziya Bobat, MBChB, MD

Role: PRINCIPAL_INVESTIGATOR

Nelson R Mandela School of Medicine, University of KwaZulu-Natal

Hoosen Coovadia, MD, MBBS

Role: PRINCIPAL_INVESTIGATOR

Doris Duke Medical Research Institute, University of KwaZulu-Natal

Locations

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Grey's Hospital

Pietermaritzburg, , South Africa

Site Status

Countries

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South Africa

Other Identifiers

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H.22.02.03.25.B1

Identifier Type: -

Identifier Source: org_study_id