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

Indiana University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Sickle Cell Disease

Treatments: Drug: Placebo; Drug: zinc sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT06561061

2023-841

Details and patient eligibility

About

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)

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 59 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Zinc

Experimental group

Description:

Dispersible zinc sulfate tablet (20 mg)

Treatment:

Drug: zinc sulfate

Placebo

Placebo Comparator group

Description:

Dispersible identical placebo tablet

Treatment:

Drug: Placebo