Trial of Zinc and HIV Progression in Children

This study is currently recruiting participants.

Verified by Harvard School of Public Health, March 2008

Sponsors and Collaborators:	Harvard School of Public Health Thrasher Research Fund Muhimbili University of Health and Allied Sciences
Information provided by:	Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00446758

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Dietary Supplement: Zinc	Phase III

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Trial of Zinc and HIV Progression in Children

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:

Morbidity from respiratory and diarrheal infections, HIV disease progression [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

growth in height and weight [ Designated as safety issue: No ]

Estimated Enrollment:	440
Study Start Date:	March 2008

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	6 Weeks to 60 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446758

Contacts

Contact: Eduardo Villamor, MD, DrPH

617-432-1238

evillamo@hsph.harvard.edu

Locations

Tanzania
Muhimbili University College of Health Sciences	Recruiting
Dar es Salaam, Tanzania
Contact: Karim Manji, MD kmanji@muchs.ac.tz
Principal Investigator: Karim Manji, MD

Sponsors and Collaborators

Harvard School of Public Health

Thrasher Research Fund

Muhimbili University of Health and Allied Sciences

Investigators

Principal Investigator:

Eduardo Villamor, MD, DrPH

Harvard School of Public Health

More Information

Responsible Party:	Harvard School of Public Health ( Eduardo Villamor, MD, DrPH )
Study ID Numbers:	14511
Study First Received:	March 12, 2007
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00446758
Health Authority:	United States: Harvard School of Public Health Human Subjects Committee; Tanzania: Muhimbili University College of Health Sciences, Dar es Salaam

Keywords provided by Harvard School of Public Health:

Zinc
HIV
Infants
Children

Morbidity
Child health outcomes
treatment naive
treatment experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Zinc
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Disease Progression
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Growth Substances
Physiological Effects of Drugs

Lentivirus Infections
Trace Elements
Micronutrients
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009