A Phase 3 interventional study of Zinc Supplements and Placebo Supplements in Neonatal Infection, sponsored by Harvard School of Public Health (HSPH). Recruiting at 1 site in Tanzania. Open to participants aged 0 Days to 59 Days. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Harvard School of Public Health (HSPH) · Phase 3, Interventional, and Treatment
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.
Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube
Dietary Supplement: Zinc Supplements
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube
Dietary Supplement: Placebo Supplements
Dispersible zinc citrate tablets
Dispersible placebo tablets
Death
All-cause infant death
Time frame: 90 Days
Treatment Failure
A composite endpoint of death during initial period of hospitalization, the need for additional respiratory support (either mechanical ventilation, or positive end expiratory pressure support) or the use of vasoactive medicines to support blood pressure or need to change antibiotics during the initial hospitalization
Time frame: From date of randomization until the date of first documented treatment failure or date of death from any cause during the initial hospitalization, whichever comes first, assessed up to 90 days
Death during initial hospitalization
All-cause mortality during initial hospitalization
Time frame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
Duration of initial hospital stay
Hours from randomization to initial hospitalization discharge
Time frame: Randomization to Day 90
Duration of signs of clinical severe infection
Hours from randomization to the absence of any sign of clinical severe infection
Time frame: Randomization to Day 90
Diarrhea during initial hospital admission
Clinical diagnosis based on three or more loose or watery stools in the past 24 hours
Time frame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
Rate of vomiting related to regimen dosing
Vomiting observed by study staff within 30 minutes of regimen dosing
Time frame: Randomization to Day 15
Re-hospitalization
Infant admitted and stayed overnight in health facility after being discharged from initial hospitalization
Time frame: Date of initial hospitalization discharge to Day 90
Presence of any sign of possible severe bacterial infection at Day 15
Presence of a clinical sign of possible severe bacterial infection, including: high body temperature ≥38°C, low body temperature \<35.5°C , severe chest indrawing, movement only on stimulation or no movement at all, stopped feeding well or unable to feed at all, or convulsions.
Time frame: Day 15
Presence of any sign of possible severe bacterial infection at Day 90
Presence of a clinical sign of possible severe bacterial infection, including: high body temperature ≥38°C, low body temperature \<35.5°C , severe chest indrawing, movement only on stimulation or no movement at all, stopped feeding well or unable to feed at all, or convulsions.
Time frame: Day 90
Proportion of Children with Diarrhea at Day 15 or Day 90
Maternal report of three or more loose or watery stools in the past 24 hours
Time frame: Day 15 and Day 90
Infant length-for-age z-score at Day 15
Infant length-for-age z-score by WHO Child Growth Standards
Time frame: Day 15
Infant length-for-age z-score at Day 90
Infant length-for-age z-score by WHO Child Growth Standards
Time frame: Day 90
Infant weight-for-age z-score at Day 15
Infant weight-for-age z-score by WHO Child Growth Standards
Time frame: Day 15
Infant weight-for-age z-score at Day 90
Infant weight-for-age z-score by WHO Child Growth Standards
Time frame: Day 90
Infant weight-for-length z-score at Day 15
Infant weight-for-length z-score by WHO Child Growth Standards
Time frame: Day 15
Infant weight-for-length z-score at Day 90
Infant weight-for-length z-score by WHO Child Growth Standard
Time frame: Day 90
Plasma zinc concentrations at Day 15
Infant plasma zinc concentration
Time frame: Day 15
Plan to share: Yes
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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