Zinc supplementation for infants with severe infections in Tanzania
Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania
PHASE3 · Harvard School of Public Health (HSPH) · NCT06102044
This study is testing if giving zinc to young infants in Tanzania who are hospitalized with serious infections can help them recover better and live longer.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 3250 (estimated) |
| Ages | 0 Days to 59 Days |
| Sex | All |
| Sponsor | Harvard School of Public Health (HSPH) (other) |
| Locations | 1 site (Dar es Salaam) |
| Trial ID | NCT06102044 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are young infants aged 0-59 days diagnosed with clinical severe infection who can feed enterally.
Not a fit: Patients who have received prior zinc supplementation during their current illness or have other serious conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce mortality rates and improve recovery outcomes for young infants suffering from severe infections.
How similar studies have performed: While the approach of zinc supplementation in this context is promising, it is relatively novel and has not been extensively tested in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dar es Salaam
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neonatal Infection