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Could zinc and a liver pill help newborns beat jaundice faster?

NCT ID NCT06517862

Disease control Sponsor: Amira Adel Fouly Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests whether giving oral zinc sulfate and ursodeoxycholic acid alongside standard light therapy can help clear jaundice faster in newborns. About 80 babies with non-hemolytic jaundice will receive one of two doses of zinc, or the liver drug UDCA, plus phototherapy. The goal is to see if these add-ons lower bilirubin levels and shorten the time babies need treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zinc sulfate and ursodeoxycholic acid
What this could lead to
If successful, this could provide a safe, simple way to speed up jaundice treatment in newborns, reducing time under phototherapy and hospital stays.
What could go wrong
This is a small, early-phase trial with only 80 babies, so results may not apply broadly. Side effects from the drugs are possible, and the benefit over phototherapy alone may be modest.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

140 people

The number who actually took part.

Started

Sep 2024

Finished

May 2026

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

1 day to 1 month

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: * neonates with both genders * neonates with gestational age ≥ 32 weeks * neonates who can tolerate enteral feeding * diagnosed with unconjugated non-hemolytic hyperbilirubinemia * Phototherapy is required within the first week of life. Exclusion Criteria: * Neonates with seizures, hydrops fetalis, hypoxic-ischemic encephalopathy, or major congenital anomalies * Neonates who have had an exchange transfusion within 24 hours * neonates have evidence of hemolytic causes of jaundice (e.g., ABO and RH * incompatibility, glucose 6-phosphate dehydrogenase deficiency) * neonates who have reported hypersensitivity to zinc sulfate or ursodeoxycholic acid.

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Conditions

The condition(s) this trial relates to.

hyperbilirubinemia Hyperbilirubinemia, Neonatal transient familial neonatal hyperbilirubinemia

As listed by the trial registrant

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

Neonatal hyperbilirubinemia

Contacts and locations

Locations

  • Neonatal Intensive Care Unit (NICU) of Ain Shams University Hospitals

    Cairo, Egypt

More trials for these conditions

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