Zinc supplementation for infants with severe infections in Tanzania

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of zinc supplementation in young infants aged 0-59 days who are hospitalized with clinical severe infections, such as sepsis, meningitis, and pneumonia. The study will enroll 3,250 infants in Tanzania and randomly assign them to receive either a 14-day course of zinc or a placebo, in addition to standard antibiotic therapy. The aim is to determine if zinc can reduce mortality and improve treatment outcomes for these vulnerable patients.

Why it matters

Who can join: the full rules

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 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

Where it's running

• Muhimbili University of Health and Allied Sciences
  Dar es Salaam, Tanzania Recruiting

Study contacts

• Principal investigator: Christopher R Sudfeld, ScD — Harvard School of Public Health (HSPH)
• Study coordinator: Christopher R Sudfeld, ScD
• Email: csudfeld@hsph.harvard.edu
• Phone: (617) 432-5051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.