Zinc Supplementation for Young Infants with Clinical Severe Infection in Tanzania

Last updated: December 27, 2024
Sponsor: Harvard School of Public Health (HSPH)
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Zinc Supplements

Placebo Supplements

Clinical Study ID

NCT06102044
IRB23-0138
  • Ages < 59
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 3250
Treatment Group(s): 2
Primary Treatment: Zinc Supplements
Phase: 3
Study Start date:
December 27, 2024
Estimated Completion Date:
October 30, 2027

Connect with a study center

  • Muhimbili University of Health and Allied Sciences

    Dar Es Salaam,
    Tanzania

    Active - Recruiting

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