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Trial of Zinc and HIV Progression in Children

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
Tanzania
Study Type
Interventional
Intervention
Zinc
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zinc, HIV, Infants, Children, Morbidity, Child health outcomes, treatment naive, treatment experienced

Eligibility Criteria

6 Weeks - 60 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muhimbili University College of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zinc

Placebo

Arm Description

zinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children < 12 mo)

Outcomes

Primary Outcome Measures

Morbidity from respiratory and diarrheal infections, HIV disease progression

Secondary Outcome Measures

growth in height and weight

Full Information

First Posted
March 12, 2007
Last Updated
September 13, 2012
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Thrasher Research Fund, Muhimbili University of Health and Allied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00446758
Brief Title
Trial of Zinc and HIV Progression in Children
Official Title
Trial of Zinc and HIV Progression in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Thrasher Research Fund, Muhimbili University of Health and Allied Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zinc, HIV, Infants, Children, Morbidity, Child health outcomes, treatment naive, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc
Arm Type
Experimental
Arm Description
zinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children < 12 mo)
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Description
zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children > 12 months.
Primary Outcome Measure Information:
Title
Morbidity from respiratory and diarrheal infections, HIV disease progression
Time Frame
every 4 to 6 months until the end of follow-up
Secondary Outcome Measure Information:
Title
growth in height and weight
Time Frame
every 4 to 6 months until the end of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Villamor, MD, DrPH
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhimbili University College of Health Sciences
City
Dar es Salaam
Country
Tanzania

12. IPD Sharing Statement

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Trial of Zinc and HIV Progression in Children

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