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

Zinc for Infection Prevention in Sickle Cell Anemia-2

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)

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Drug: zinc sulfate; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Uganda
  • Jinja, Uganda
    • Jinja Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zinc; Dispersible zinc sulfate tablet (20 mg)	Drug: zinc sulfate; Dispersible (20 mg) tablet
Placebo Comparator: Placebo; Dispersible identical placebo tablet	Drug: Placebo; Dispersible tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint	Change in TCD Velocity	6 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Makerere University; Global Health Uganda LTD
• Investigators: Principal Investigator: Chandy C John, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Actual): November 7, 2025
• Study Completion (Actual): November 7, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Zinc; All-cause infections
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell; Sulfur Compounds; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Zinc Compounds; Zinc Sulfate
• Other Study ID Numbers: 2023-841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No