Neonatal InfectionPhase 3NCT06102044
Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
A Phase 3 study testing Zinc Supplements in people with Neonatal Infection, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 59 days
- Conditions the study is for
- Neonatal Infection
- What is being tested?
- Zinc Supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,250 participants
- Where
- 1 siteTanzania
- Study dates
- 27 Dec 2024to 30 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 59 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tanzania1 site, 1 recruiting
- Recruiting
Muhimbili University of Health and Allied Sciences
Dar es Salaam
Karim P Manji, MD
About this study
Official title: Trial of Zinc Supplements 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.
- Conditions
- Neonatal Infection
- Being tested
- Zinc Supplements, Placebo Supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SupplementsDietary supplement
Dispersible zinc citrate tablets
Placebo SupplementsDietary supplement
Dispersible placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Zinc Supplementation | Experimental | 14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube Receives: Dietary Supplement: Zinc Supplements |
| Placebo | Placebo comparator | 14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube Receives: Dietary Supplement: Placebo Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All-cause infant death
Measured: 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
Measured: 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
Secondary outcomes (16)
Death during initial hospitalization
All-cause mortality during initial hospitalization
Measured: 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
Measured: Randomization to Day 90
Duration of signs of clinical severe infection
Hours from randomization to the absence of any sign of clinical severe infection
Measured: 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
Measured: 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
Measured: Randomization to Day 15
Re-hospitalization
Infant admitted and stayed overnight in health facility after being discharged from initial hospitalization
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 15
Infant length-for-age z-score at Day 90
Infant length-for-age z-score by WHO Child Growth Standards
Measured: Day 90
Infant weight-for-age z-score at Day 15
Infant weight-for-age z-score by WHO Child Growth Standards
Measured: Day 15
Infant weight-for-age z-score at Day 90
Infant weight-for-age z-score by WHO Child Growth Standards
Measured: Day 90
Infant weight-for-length z-score at Day 15
Infant weight-for-length z-score by WHO Child Growth Standards
Measured: Day 15
Infant weight-for-length z-score at Day 90
Infant weight-for-length z-score by WHO Child Growth Standard
Measured: Day 90
Plasma zinc concentrations at Day 15
Infant plasma zinc concentration
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start27 Dec 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Responsible party
- Principal investigator, Christopher Robert Sudfeld, Harvard School of Public Health (HSPH)
- Investigators
- Christopher R Sudfeld, ScD, Principal investigator, Harvard School of Public Health (HSPH)Christopher P Duggan, MD, Principal investigator, Harvard School of Public Health (HSPH) and Boston Children's HospitalKarim P Manji, MD, Principal investigator, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102044
- Sponsor's protocol ID
- IRB23-0138
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Manji KP, Somji S, Bakari M, Fawzi WW, Kibwana U, Kisenge R, Kisumuni AS, Liu E, Mafie N, Maleko FA, Salim N, Duggan CP, Sudfeld CR. Efficacy of zinc supplementation for young infants with clinical severe infection in Tanzania: study protocol for a randomised controlled trial. BMJ Paediatr Open. 2025 Aug 14;9(1):e003804. doi: 10.1136/bmjpo-2025-003804.
PubMed 40813142
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania
- ClinicalTrials.gov ID
- NCT06102044
- Acronym / sponsor ID
- IRB23-0138
- Conditions
- Neonatal Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,250 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc Supplementation | Experimental | Dietary Supplement: Zinc Supplements14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Supplements14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube |
Who may qualify
- Ages
- 0 to 59 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc SupplementsDispersible zinc citrate tablets | Dietary supplement | Zinc Supplementation |
| Placebo SupplementsDispersible placebo tablets | Dietary supplement | Placebo |
Primary outcome
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
16 secondary outcomes
Death during initial hospitalization
Time frame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
Duration of initial hospital stay
Time frame: Randomization to Day 90
Duration of signs of clinical severe infection
Time frame: Randomization to Day 90
Diarrhea during initial hospital admission
Time frame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
Rate of vomiting related to regimen dosing
Time frame: Randomization to Day 15
Re-hospitalization
Time frame: Date of initial hospitalization discharge to Day 90
Presence of any sign of possible severe bacterial infection at Day 15
Time frame: Day 15
Presence of any sign of possible severe bacterial infection at Day 90
Time frame: Day 90
Proportion of Children with Diarrhea at Day 15 or Day 90
Time frame: Day 15 and Day 90
Infant length-for-age z-score at Day 15
Time frame: Day 15
Infant length-for-age z-score at Day 90
Time frame: Day 90
Infant weight-for-age z-score at Day 15
Time frame: Day 15
Infant weight-for-age z-score at Day 90
Time frame: Day 90
Infant weight-for-length z-score at Day 15
Time frame: Day 15
Infant weight-for-length z-score at Day 90
Time frame: Day 90
Plasma zinc concentrations at Day 15
Time frame: Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 40813142Manji KP, Somji S, Bakari M, Fawzi WW, Kibwana U, Kisenge R, Kisumuni AS, Liu E, Mafie N, Maleko FA, Salim N, Duggan CP, Sudfeld CR. Efficacy of zinc supplementation for young infants with clinical severe infection in Tanzania: study protocol for a randomised controlled trial. BMJ Paediatr Open. 2025 Aug 14;9(1):e003804. doi: 10.1136/bmjpo-2025-003804.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher R Sudfeld, ScD principal investigator
Harvard School of Public Health (HSPH)
Christopher P Duggan, MD principal investigator
Harvard School of Public Health (HSPH) and Boston Children's Hospital
Karim P Manji, MD principal investigator
Muhimbili University of Health and Allied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zinc Supplements in people with Neonatal Infection, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher R Sudfeld, ScD ((617) 432-5051, csudfeld@hsph.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 90 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06102044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.