Clinical Research Directory
Browse clinical research sites, groups, and studies.
Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
Sponsor: Harvard School of Public Health (HSPH)
Summary
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.
Official title: Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania
Key Details
Gender
All
Age Range
0 Days - 59 Days
Study Type
INTERVENTIONAL
Enrollment
3250
Start Date
2024-12-27
Completion Date
2027-10-30
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
Zinc Supplements
Dispersible zinc citrate tablets
Placebo Supplements
Dispersible placebo tablets
Locations (1)
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania