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Completed

NCT Number: NCT00446758

Trial of Zinc and HIV Progression in Children

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

6 week–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Muhimbili University College of Health Sciences

Dar es Salaam, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc

Dietary Supplement

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

Primary outcomes

  1. Morbidity from respiratory and diarrheal infections, HIV disease progression

    Time frame: every 4 to 6 months until the end of follow-up

Secondary outcomes

  1. growth in height and weight

    Time frame: every 4 to 6 months until the end of follow-up

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences
  • Thrasher Research Fund

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 13, 2007
Registry last updated
Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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