Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

Indiana University

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Other: Placebo; Dietary Supplement: Zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT03528434

1712339562

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 250 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (10 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 12 months. The primary study outcome will be incidence of severe or invasive infections. Secondary outcomes will include incidence of all clinical infections, confirmed bacterial infections (by culture or PCR), incidence of vaso-occlusive crisis (VOC), change in height-for-age z-score, and incidence of zinc-related adverse events.

Enrollment: 250 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)
2. Age range of 1.00-4.99 years, inclusive, at the time of enrollment
3. Weight at least 5.0 kg at the time of enrollment
4. Willingness to comply with all study-related treatments, evaluations, and follow-up

Exclusion criteria

1. Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
2. Severe malnutrition determined by impaired growth parameters as defined by the World Health Organization (WHO) (weight for length/height or height for age z-score <-3, using WHO growth standards)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups, including a placebo group

Zinc

Experimental group

Description:

Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet

Treatment:

Dietary Supplement: Zinc

Placebo

Placebo Comparator group

Description:

Dispersible tablet with inert ingredients, identical to zinc in appearance

Treatment:

Other: Placebo