NCT06561061

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

Zinc for Infection Prevention in Sickle Cell Anemia-2

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	zinc sulfate	Dispersible (20 mg) tablet
DRUG	Placebo	Dispersible tablet

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-11-07
• Completion: 2025-11-07
• First posted: 2024-08-19
• Last updated: 2026-01-30

Locations

1 site across 1 country: Uganda