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RECRUITING
NCT06102044
PHASE3

Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Sponsor: Harvard School of Public Health (HSPH)

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Zinc Supplements

Dispersible zinc citrate tablets

DIETARY_SUPPLEMENT

Placebo Supplements

Dispersible placebo tablets

Locations (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania