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

NCT ID: NCT06561061

Last Updated: 2025-02-13

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

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2025-11-30

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 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).

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized double-blinded placebo-controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Double-blinded placebo-controlled trial

Study Groups

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Zinc

Dispersible zinc sulfate tablet (20 mg)

Group Type EXPERIMENTAL

zinc sulfate

Intervention Type DRUG

Dispersible (20 mg) tablet

Placebo

Dispersible identical placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dispersible tablet

Interventions

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zinc sulfate

Dispersible (20 mg) tablet

Intervention Type DRUG

Placebo

Dispersible tablet

Intervention Type DRUG

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
* 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)
Minimum Eligible Age

12 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Global Health Uganda LTD

OTHER

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Chandy John

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chandy C John, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Jinja Hospital

Jinja, , Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Isaac Birungi

Role: CONTACT

0704236193 ext. +256

Ruth Namazzi, MBChB

Role: CONTACT

0772356331 ext. +256

Facility Contacts

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Isaac Birungi

Role: primary

Other Identifiers

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2023-841

Identifier Type: -

Identifier Source: org_study_id

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