Zinc supplementation of HIV-1 infected children Infections and Infestations
Conditions
Interventions
Patients are randomised into one of the three arms:
Group A - placebo
Group B - low dose zinc supplement
Group C - high dose zinc supplement
Trial drugs are given orally daily over 6 weeks and child
Sponsors
University of Cape Town, The Child Health Unit (South Africa)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically stable 2. Vertically transmitted HIV-1 infected children 3. Attending the Infectious Diseases Clinic at Red Cross Children's Hospital 4. Aged 6 months to 6 years
Exclusion criteria
Exclusion criteria: 1. HIV-infected children aged less than 6 months 2. Children with an intercurrent infection or axillary temperature of >38 °C 3. Children with any invasive opportunistic infection including tuberculosis 4. Children with bronchiectasis 5. Children who had received high dose vitamin A, trace elements or zinc supplements within the preceding 8 weeks 6. Children recently hospitalised
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. No increase in viral loads 2. No reduction in CD4 counts 3. No deaths 4. Laboratory indicators of safety | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. An improvement in immune function on zinc supplementation 2. A reduction in infective events 3. A reduction in admissions to hospital | — |
Countries
South Africa
Outcome results
None listed