Status:
RECRUITING
Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Global Health Uganda LTD
Makerere University
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
12-59 years
Phase:
PHASE2
PHASE3
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 100 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (20 mg oral dispersible tablet daily) or...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06561061
Start Date
February 10 2025
End Date
November 30 2025
Last Update
February 13 2025
Active Locations (1)
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1
Jinja Hospital
Jinja, Uganda