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

Indiana University100 enrolled

Overview

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)

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Sickle Cell Disease

Interventions

zinc sulfateDRUG

Dispersible (20 mg) tablet

PlaceboDRUG

Dispersible tablet

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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)

Locations (1)

Jinja Hospital

Jinja, Uganda

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Incidence of infections requiring hospitalization

Incidence of Advance events greater or equal to grade 3

Time frame: 6 months

Incidence of adverse events requiring discontinuation of study drug

Incidence of Zinc related Advance events

Time frame: 6 months

Incidence of stroke or death

Incidence of death and stroke

Time frame: 6 months

Data from ClinicalTrials.gov

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