Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)

Phase 2

Recruiting

• Conditions: Sickle Cell Disease
• Interventions: Drug: Placebo; Drug: zinc sulfate

• Registration Number: NCT06561061
• Lead Sponsor: Indiana University

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 placebo (identical to zinc in appearance) for 6 months. The primary study outcome will be incidence of infection (all causes).

Study Timeline

• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-19
• Status Verified: 2025-02
• Study Start: 2025-02-10
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dispersible identical placebo tablet
Zinc	zinc sulfate	Dispersible zinc sulfate tablet (20 mg)

Primary Outcome Measures

Name	Time	Method
Incidence of all-cause infections in the zinc vs. placebo groups	6 months	Will assess the difference in the incidence of all cause infection between the Placebo arm and the experimental arm

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events requiring discontinuation of study drug	6 months	Incidence of Zinc related Advance events
Incidence of infections requiring hospitalization	6 months	Incidence of Advance events greater or equal to grade 3
Incidence of stroke or death	6 months	Incidence of death and stroke

Trial Locations

Locations (1)

Jinja Hospital; 🇺🇬 Jinja, Uganda