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

Last updated: February 12, 2025
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

Placebo

zinc sulfate

Clinical Study ID

NCT06561061
2023-841
  • Ages 12-59
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Known other chronic medical condition (e.g., HIV, malignancy, active clinicaltuberculosis)

  • 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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
February 10, 2025
Estimated Completion Date:
November 30, 2025

Study 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).

Connect with a study center

  • Jinja Hospital

    Jinja,
    Uganda

    Active - Recruiting

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