Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Neonatal Infection

In brief

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.

Key facts

Study ID

NCT06102044

Run by

Harvard School of Public Health (HSPH)

People needed

3250

Starts

2024-12-27

Expected to finish

2027-10-30

Last updated by the study team

2025-12-12

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Muhimbili University of Health and Allied Sciences — Dar es Salaam, Tanzania (enrolling)

Full record on ClinicalTrials.gov

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