Trial of Zinc and HIV Progression in Children

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Dietary Supplement: Zinc

• Registration Number: NCT00446758
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief Summary

To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.

Detailed Description

The purpose of this study is to examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.

Study Timeline

• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-13
• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

• HIV Infected Children under 60 months of age presenting at HIV treatment clinics in Dar es Salaam, Tanzania

Exclusion Criteria

Eligible for ART: CD4 cell counts < 20% or above pediatric clinical stage of HIV disease 3 according to WHO staging system.

Severe acute malnutrition; Major congenital malformations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Zinc	-
Zinc	Zinc	zinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children \< 12 mo)

Primary Outcome Measures

Name	Time	Method
Morbidity from respiratory and diarrheal infections, HIV disease progression	every 4 to 6 months until the end of follow-up

Secondary Outcome Measures

Name	Time	Method
growth in height and weight	every 4 to 6 months until the end of follow-up

Trial Locations

Locations (1)

Muhimbili University College of Health Sciences; 🇹🇿 Dar es Salaam, Tanzania