Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Dietary Supplement: Zinc; Other: Placebo

• Registration Number: NCT03528434
• Lead Sponsor: Indiana University

Brief Summary

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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-17
• Study Start: 2019-03-14
• Primary Completion: 2020-11-23
• Study Completion: 2020-11-23
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc	Zinc	Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet
Placebo	Placebo	Dispersible tablet with inert ingredients, identical to zinc in appearance

Primary Outcome Measures

Name	Time	Method
Incidence of infection	12 months	The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.

Secondary Outcome Measures

Name	Time	Method
Incidence of vaso-occlusive crisis (VOC)	12 months	Incidence of vaso-occlusive crisis (VOC)
Change in height-for-age z-score	Enrollment to 12 months	Change in height-for-age z-score
Incidence of zinc-related adverse events	12 months	Incidence of zinc-related adverse events
Incidence of all clinical infections	12 months	Incidence of all clinical infections
Incidence of confirmed bacterial infections (by culture or PCR)	12 months	Incidence of confirmed bacterial infections (by culture or PCR)

Trial Locations

Locations (1)

Jinja Reginal Referral Hospital; 🇺🇬 Jinja, Uganda