Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
NCT ID: NCT06102044
Last Updated: 2025-12-12
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
PHASE3
3250 participants
INTERVENTIONAL
2024-12-27
2027-10-30
Brief Summary
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The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Zinc Supplementation
14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube
Zinc Supplements
Dispersible zinc citrate tablets
Placebo
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube
Placebo Supplements
Dispersible placebo tablets
Interventions
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Zinc Supplements
Dispersible zinc citrate tablets
Placebo Supplements
Dispersible placebo tablets
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of clinical severe infection (CSI)
* Ability to feed enterally
* Intend to stay in the study area for 90 days
* Provided informed consent
Exclusion Criteria
* Receipt of antibiotics for \>24 hours before enrollment
* Diarrhea at enrollment
* Signs suggestive of serious illness/condition that is not clinical severe infection
* Previously enrolled in the trial
* Enrolled in other research study
0 Days
59 Days
ALL
No
Sponsors
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Harvard School of Public Health (HSPH)
OTHER
Muhimbili University of Health and Allied Sciences
OTHER
Responsible Party
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Christopher Robert Sudfeld
Associate Professor of Global Health and Nutrition
Principal Investigators
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Christopher R Sudfeld, ScD
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Christopher P Duggan, MD
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH) and Boston Children's Hospital
Karim P Manji, MD
Role: PRINCIPAL_INVESTIGATOR
Muhimbili University of Health and Allied Sciences
Locations
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Muhimbili University of Health and Allied Sciences
Dar es Salaam, , Tanzania
Countries
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Central Contacts
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Facility Contacts
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Karim P Manji, MD
Role: primary
References
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Manji KP, Somji S, Bakari M, Fawzi WW, Kibwana U, Kisenge R, Kisumuni AS, Liu E, Mafie N, Maleko FA, Salim N, Duggan CP, Sudfeld CR. Efficacy of zinc supplementation for young infants with clinical severe infection in Tanzania: study protocol for a randomised controlled trial. BMJ Paediatr Open. 2025 Aug 14;9(1):e003804. doi: 10.1136/bmjpo-2025-003804.
Other Identifiers
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IRB23-0138
Identifier Type: -
Identifier Source: org_study_id
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