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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
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Zinc and HIV Progression in Children

Resource links provided by NLM:


Further study details as provided by Eduardo Villamor, 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 ]

Secondary Outcome Measures:
  • growth in height and weight [ Time Frame: every 4 to 6 months until the end of follow-up ]

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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

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

ClinicalTrials.gov processed this record on June 27, 2017