Sickle Cell Disease
Conditions
Keywords
Zinc
Brief summary
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).
Detailed description
The study will be a randomized, placebo-controlled, double blind clinical trial in which 250 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (10 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 12 months. The primary study outcome will be incidence of severe or invasive infections. Secondary outcomes will include incidence of all clinical infections, confirmed bacterial infections (by culture or PCR), incidence of vaso-occlusive crisis (VOC), change in height-for-age z-score, and incidence of zinc-related adverse events.
Interventions
DIETARY_SUPPLEMENTZinc
10mg dispersible zinc sulfate tablet
OTHERPlacebo
Dispersible tablet with inert ingredients, identical to zinc in appearance
Sponsors
Children's Hospital Medical Center, Cincinnati
Makerere University
Jinja Regional Referral Hospital
Université de Montréal
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A randomized, placebo-controlled, double blind clinical trial
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
1. Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis) 2. Age range of 1.00-4.99 years, inclusive, at the time of enrollment 3. Weight at least 5.0 kg at the time of enrollment 4. Willingness to comply with all study-related treatments, evaluations, and follow-up
Exclusion criteria
1. Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis) 2. Severe malnutrition determined by impaired growth parameters as defined by the World Health Organization (WHO) (weight for length/height or height for age z-score \<-3, using WHO growth standards)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infection | 12 months | The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all clinical infections | 12 months | Incidence of all clinical infections |
| Incidence of confirmed bacterial infections (by culture or PCR) | 12 months | Incidence of confirmed bacterial infections (by culture or PCR) |
| Incidence of vaso-occlusive crisis (VOC) | 12 months | Incidence of vaso-occlusive crisis (VOC) |
| Change in height-for-age z-score | Enrollment to 12 months | Change in height-for-age z-score |
| Incidence of zinc-related adverse events | 12 months | Incidence of zinc-related adverse events |
Countries
Uganda
Outcome results
None listed