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Completed

NCT Number: NCT06561061

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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

12 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Jinja Hospital

Jinja, Uganda

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

zinc sulfate

Drug

Dispersible (20 mg) tablet

Placebo

Drug

Dispersible tablet

Primary outcomes

  1. Incidence of all-cause infections in the zinc vs. placebo groups

    Time frame: 6 months

    Will assess the difference in the incidence of all cause infection between the Placebo arm and the experimental arm

Secondary outcomes

  1. Incidence of infections requiring hospitalization

    Time frame: 6 months

    Incidence of Advance events greater or equal to grade 3

  2. Incidence of adverse events requiring discontinuation of study drug

    Time frame: 6 months

    Incidence of Zinc related Advance events

  3. Incidence of stroke or death

    Time frame: 6 months

    Incidence of death and stroke

Other outcomes

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

    Time frame: 6 months

    Change in TCD Velocity

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Global Health Uganda LTD
  • Makerere University

Registry information

Official study title

Zinc for Infection Prevention in Sickle Cell Anemia-2

Acronym: ZIPS-2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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