Last updated: December 27, 2024
Sponsor: Harvard School of Public Health (HSPH)
Overall Status: Active - Recruiting
Phase
3
Condition
N/ATreatment
Zinc Supplements
Placebo Supplements
Clinical Study ID
NCT06102044
IRB23-0138
Ages < 59 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Young infants aged 0-59 days
Diagnosis of clinical severe infection (CSI)
Ability to feed enterally
Intend to stay in the study area for 90 days
Provided informed consent
Exclusion
Exclusion Criteria:
Prior use of zinc supplements during the current illness
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
Study Design
Total Participants: 3250
Treatment Group(s): 2
Primary Treatment: Zinc Supplements
Phase: 3
Study Start date:
December 27, 2024
Estimated Completion Date:
October 30, 2027
Connect with a study center
Muhimbili University of Health and Allied Sciences
Dar Es Salaam,
TanzaniaActive - Recruiting
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