Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

Study Overview
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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).

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.

Official Title
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for Infection Prevention in Sickle Cell Anemia (ZIPS)

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Dietary Supplement: Zinc
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis) 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)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, placebo-controlled, double blind clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc<br>Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet | Dietary Supplement: Zinc<br>* 10mg dispersible zinc sulfate tablet<br>|
| Placebo Comparator: Placebo<br>Dispersible tablet with inert ingredients, identical to zinc in appearance | Other: Placebo<br>* Dispersible tablet with inert ingredients, identical to zinc in appearance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infection | The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation. | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc