Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-14

Study Completion Date

2020-11-23

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, placebo-controlled, double blind clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Zinc

Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet

Group Type EXPERIMENTAL

Zinc

Intervention Type DIETARY_SUPPLEMENT

10mg dispersible zinc sulfate tablet

Placebo

Dispersible tablet with inert ingredients, identical to zinc in appearance

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Dispersible tablet with inert ingredients, identical to zinc in appearance

Interventions

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Zinc

10mg dispersible zinc sulfate tablet

Intervention Type DIETARY_SUPPLEMENT

Placebo

Dispersible tablet with inert ingredients, identical to zinc in appearance

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No