Trial of Zinc and HIV Progression in Children

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Dietary Supplement: Zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT00446758

14511

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 patients

Sex: All

Ages: 6 weeks to 60 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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440 participants in 2 patient groups, including a placebo group

Zinc

Experimental group

Description:

zinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children \< 12 mo)

Treatment:

Dietary Supplement: Zinc

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Zinc