NCT06102044

Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,250 (estimated)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 0 Days – 59 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Zinc Supplements	Dispersible zinc citrate tablets
DIETARY_SUPPLEMENT	Placebo Supplements	Dispersible placebo tablets

Timeline

• Start date: 2024-12-27
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2023-10-26
• Last updated: 2025-12-12

Locations

1 site across 1 country: Tanzania