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Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

NCT06102044 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3250

Last updated 2025-12-12

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Zinc Supplements

Dispersible zinc citrate tablets

DIETARY_SUPPLEMENT

Placebo Supplements

Dispersible placebo tablets

Sponsors & Collaborators

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Christopher R Sudfeld, ScD · Harvard School of Public Health (HSPH)

  • Christopher P Duggan, MD · Harvard School of Public Health (HSPH) and Boston Children's Hospital

  • Karim P Manji, MD · Muhimbili University of Health and Allied Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
59 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-27
Primary Completion
2027-10-30
Completion
2027-10-30

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06102044 on ClinicalTrials.gov