Trial of Zinc and HIV Progression in Children

HIV Infections Clinical Trial

Official title:

Trial of Zinc and HIV Progression in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446758
• Other study ID #: 14511
• Status: Completed
• Phase: Phase 3
• First received: March 12, 2007
• Last updated: September 13, 2012
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: September 2012
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 60 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Dietary Supplement:
• Zinc
zinc effervescent tablets: 6.25mg to infants =12 months and 12.5 mg to children > 12 months.

Locations

Country	Name	City	State
Tanzania	Muhimbili University College of Health Sciences	Dar es Salaam

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health	Muhimbili University of Health and Allied Sciences, Thrasher Research Fund

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity from respiratory and diarrheal infections, HIV disease progression		every 4 to 6 months until the end of follow-up	Yes
Secondary	growth in height and weight		every 4 to 6 months until the end of follow-up	No