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Trial of Zinc and HIV Progression in Children

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Eduardo Villamor, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00446758
First received: March 12, 2007
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Zinc and HIV Progression in Children

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Primary Outcome Measures:
  • Morbidity from respiratory and diarrheal infections, HIV disease progression [ Time Frame: every 4 to 6 months until the end of follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • growth in height and weight [ Time Frame: every 4 to 6 months until the end of follow-up ] [ Designated as safety issue: No ]

Enrollment: 440
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc
zinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children < 12 mo)
 Dietary Supplement: Zinc
zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children > 12 months.
Placebo Comparator: Placebo Dietary Supplement: Zinc
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

Locations
Tanzania
Muhimbili University College of Health Sciences
Dar es Salaam, Tanzania
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

No publications provided

Responsible Party: Eduardo Villamor, Adjunct Associate Professor of International Nutrition, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00446758     History of Changes
Other Study ID Numbers: 14511
Study First Received: March 12, 2007
Last Updated: September 13, 2012
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Harvard School of Public Health:
Zinc
HIV
Infants
Children
 Morbidity
Child health outcomes
treatment naive
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Slow Virus Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013