Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania
Location status: Recruiting
Location contact
Karim P Manji, MD
CONTACT
Recruiting
NCT Number: NCT06102044
Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
0 day–59 day
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 and study plan
Zinc Supplements
Dietary SupplementDispersible zinc citrate tablets
Placebo Supplements
Dietary SupplementDispersible placebo tablets
Primary outcomes
-
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 outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Harvard School of Public Health (HSPH)
Other
Collaborators
- Muhimbili University of Health and Allied Sciences
Registry information
Official study title
Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Oct 26, 2023
- Registry last updated
- Dec 12, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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