Safety and Efficacy of Zinc Supplementation in HIV-1-Infe... | NCT00138047

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

NCT00138047

Sponsor

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Last Update Posted

Dec 5, 2005Estimated

Enrollment

100

Phase

Phase 2

Conditions

HIV Infections

Interventions

zinc supplementation

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Sep 2004

First Submitted Date

Aug 26, 2005

First Submission Date that Met QC Criteria

Aug 26, 2005

First Posted Date

Aug 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2005

Last Update Posted Date

Dec 5, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Johns Hopkins Bloomberg School of Public HealthOTHER

Collaborators

Name	Class
United States Agency for International Development (USAID)	FED
University of KwaZulu	OTHER
Grey's Hospital	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
zinc supplementation	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mean difference in log10 HIV-1 viral load at each visit

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

60 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Grey's Hospital		Pietermaritzburg			South Africa

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided