HIV Infections
Conditions
Keywords
Zinc, HIV, Infants, Children, Morbidity, Child health outcomes, treatment naive, treatment experienced
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.
Interventions
DIETARY_SUPPLEMENTZinc
zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children \> 12 months.
Sponsors
Thrasher Research Fund
Muhimbili University of Health and Allied Sciences
Harvard School of Public Health (HSPH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 60 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morbidity from respiratory and diarrheal infections, HIV disease progression | every 4 to 6 months until the end of follow-up |
Secondary
| Measure | Time frame |
|---|---|
| growth in height and weight | every 4 to 6 months until the end of follow-up |
Countries
Tanzania
Outcome results
None listed