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Trial of Zinc and HIV Progression in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00446758
First Posted: March 13, 2007
Last Update Posted: September 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Thrasher Research Fund
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Eduardo Villamor, Harvard School of Public Health
March 12, 2007
March 13, 2007
September 14, 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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Sexes Eligible for Study: All
6 Weeks to 60 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
 
NCT00446758
14511
No
Not Provided
Not Provided
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