Overview
A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA)
Description
The study will be a randomized, placebo-controlled, double blind clinical trial in which 100 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (20 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 6 months. The primary study outcome will be incidence of infection (all causes).
Eligibility
Inclusion Criteria:
- Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)
- Age range of 1.00-4.99 years, inclusive, at the time of enrollment
- Weight at least 5.0 kg at the time of enrollment
- Willingness to comply with all study-related treatments, evaluations, and follow-up
- Children whose parents or guardians give full written informed consent
Exclusion Criteria:
- Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
- Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age z-score <-3, using WHO growth standards)
- Absolute neutropenia (absolute neutrophil count <500)