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Could a simple zinc pill save thousands of newborns from deadly infections?

NCT ID NCT06102044

Disease control Sponsor: Harvard School of Public Health (HSPH) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving zinc supplements along with standard antibiotics can reduce deaths and improve recovery in young infants (0-59 days old) hospitalized with severe infections like sepsis or pneumonia. About 3,250 babies in Tanzania will receive either zinc or a placebo for 14 days. The goal is to see if zinc lowers the risk of death or the need for extra breathing or blood pressure support.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 59 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

infectious disease neonatal sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neonatal infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Muhimbili University of Health and Allied Sciences

    RECRUITING

    Dar es Salaam, Tanzania

More trials for these conditions

Other studies related to the condition(s) this trial covers.