Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
Neonatal Infection
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 0 days - 59 days
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 3250 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
Zinc Supplementation
14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube
Dietary Supplement: Zinc Supplements
Placebo
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube
Dietary Supplement: Placebo Supplements
Zinc Supplements DIETARY_SUPPLEMENT
Dispersible zinc citrate tablets
Placebo Supplements DIETARY_SUPPLEMENT
Dispersible placebo tablets
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Death
Time frame: 90 Days
All-cause infant death
Treatment Failure
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
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
Secondary measures
Death during initial hospitalization
Time frame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
All-cause mortality during initial hospitalization
Duration of initial hospital stay
Time frame: Randomization to Day 90
Hours from randomization to initial hospitalization discharge
Duration of signs of clinical severe infection
Time frame: Randomization to Day 90
Hours from randomization to the absence of any sign of clinical severe infection
Diarrhea during initial hospital admission
Time frame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
Clinical diagnosis based on three or more loose or watery stools in the past 24 hours
Rate of vomiting related to regimen dosing
Time frame: Randomization to Day 15
Vomiting observed by study staff within 30 minutes of regimen dosing
Re-hospitalization
Time frame: Date of initial hospitalization discharge to Day 90
Infant admitted and stayed overnight in health facility after being discharged from initial hospitalization
Presence of any sign of possible severe bacterial infection at Day 15
Time frame: 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.
Presence of any sign of possible severe bacterial infection at Day 90
Time frame: 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.
Proportion of Children with Diarrhea at Day 15 or Day 90
Time frame: Day 15 and Day 90
Maternal report of three or more loose or watery stools in the past 24 hours
Infant length-for-age z-score at Day 15
Time frame: Day 15
Infant length-for-age z-score by WHO Child Growth Standards
Infant length-for-age z-score at Day 90
Time frame: Day 90
Infant length-for-age z-score by WHO Child Growth Standards
Infant weight-for-age z-score at Day 15
Time frame: Day 15
Infant weight-for-age z-score by WHO Child Growth Standards
Infant weight-for-age z-score at Day 90
Time frame: Day 90
Infant weight-for-age z-score by WHO Child Growth Standards
Infant weight-for-length z-score at Day 15
Time frame: Day 15
Infant weight-for-length z-score by WHO Child Growth Standards
Infant weight-for-length z-score at Day 90
Time frame: Day 90
Infant weight-for-length z-score by WHO Child Growth Standard
Plasma zinc concentrations at Day 15
Time frame: Day 15
Infant plasma zinc concentration
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Muhimbili University of Health and Allied SciencesDar es Salaam, TanzaniaRecruiting
Study team and timeline
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Study start
- Dec 27, 2024 Actual
- Primary completion
- Jan 1, 2028 Estimated
- Study completion
- Jan 1, 2028 Estimated
- First posted
- Oct 26, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026