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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

March 12, 2007
September 13, 2012
March 2008
March 2009   (final data collection date for primary outcome measure)
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 ]
Morbidity from respiratory and diarrheal infections, HIV disease progression
Complete list of historical versions of study NCT00446758 on ClinicalTrials.gov Archive Site
growth in height and weight [ Time Frame: every 4 to 6 months until the end of follow-up ] [ Designated as safety issue: No ]
growth in height and weight
Not Provided
Not Provided
 
Trial of Zinc and HIV Progression in Children
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
Dietary Supplement: Zinc
zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children > 12 months.
  • Experimental: Zinc
    zinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children < 12 mo)
    Intervention: Dietary Supplement: Zinc
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Zinc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
440
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
6 Weeks to 60 Months
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00446758
14511
No
Eduardo Villamor, Harvard School of Public Health
Harvard School of Public Health
  • Thrasher Research Fund
  • Muhimbili University of Health and Allied Sciences
Principal Investigator: Eduardo Villamor, MD, DrPH Harvard School of Public Health
Harvard School of Public Health
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP