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

NCT06561061 | Completed Phase 2 DMC

• 1 other identifier: 2023-841
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Sickle Cell Disease

Keywords

Zinc; All-cause infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of infections requiring hospitalization

  6 months

• Incidence of adverse events requiring discontinuation of study drug

  6 months

• Incidence of stroke or death

  6 months

Other Outcomes (1)

• Change in Transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint

  6 months

Study Arms (2)

Zinc

EXPERIMENTAL

Dispersible zinc sulfate tablet (20 mg)

Drug: zinc sulfate

Placebo

PLACEBO COMPARATOR

Dispersible identical placebo tablet

Drug: Placebo

Interventions

Placebo DRUG

Dispersible tablet

Placebo

zinc sulfate DRUG

Dispersible (20 mg) tablet

Zinc

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Makerere University: collaborator
• Indiana University: lead
• Global Health Uganda LTD: collaborator

Study Sites (1)

Jinja Hospital

Jinja, Uganda

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Chandy C John, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded placebo-controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: A randomized double-blinded placebo-controlled trial

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 19, 2024
• Study Start: February 10, 2025
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: January 30, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)