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Trial of Zinc and HIV Progression in Children

NCT ID: NCT00446758

Last Updated: 2012-09-14

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

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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Zinc HIV Infants Children Morbidity Child health outcomes treatment naive treatment experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zinc

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

Group Type EXPERIMENTAL

Zinc

Intervention Type DIETARY_SUPPLEMENT

zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children \> 12 months.

Placebo

Group Type PLACEBO_COMPARATOR

Zinc

Intervention Type DIETARY_SUPPLEMENT

zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children \> 12 months.

Interventions

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Zinc

zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children \> 12 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thrasher Research Fund

OTHER

Sponsor Role collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Villamor

Adjunct Associate Professor of International Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eduardo Villamor, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

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Muhimbili University College of Health Sciences

Dar es Salaam, , Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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14511

Identifier Type: -

Identifier Source: org_study_id