Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)
NCT ID: NCT06561061
Last Updated: 2025-02-13
Study Results
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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RECRUITING
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2025-02-10
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Zinc
Dispersible zinc sulfate tablet (20 mg)
zinc sulfate
Dispersible (20 mg) tablet
Placebo
Dispersible identical placebo tablet
Placebo
Dispersible tablet
Interventions
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zinc sulfate
Dispersible (20 mg) tablet
Placebo
Dispersible tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
12 Months
59 Months
ALL
No
Sponsors
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Global Health Uganda LTD
OTHER
Makerere University
OTHER
Indiana University
OTHER
Responsible Party
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Chandy John
Professor of Pediatrics
Principal Investigators
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Chandy C John, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Jinja Hospital
Jinja, , Uganda
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-841
Identifier Type: -
Identifier Source: org_study_id
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