Actively Recruiting
Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
Led by Harvard School of Public Health (HSPH) · Updated on 2025-12-12
3250
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
H
Harvard School of Public Health (HSPH)
Lead Sponsor
M
Muhimbili University of Health and Allied Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection. 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.
CONDITIONS
Official Title
Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania
Actively Recruiting
Research Team
C
Christopher R Sudfeld, ScD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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