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One vitamin a pill before transplant: a new shield against a deadly complication?

NCT ID NCT06450925

Disease control Sponsor: Children's Hospital Medical Center, Cincinnati 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests whether giving a single high dose of vitamin A before an allogeneic stem cell transplant can reduce the chance of developing moderate-to-severe chronic graft-versus-host disease (GVHD), a common and serious complication. Adults scheduled for a stem cell transplant will receive either vitamin A or a placebo pill before the procedure. Researchers will track how many participants develop chronic GVHD, as well as other outcomes like relapse and overall survival.

What this could mean

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

Active substance
Vitamin A (oral supplement)
What this could lead to
If effective, a single vitamin A dose before transplant could reduce the risk of chronic graft-versus-host disease, improving recovery and quality of life for stem cell recipients.
What could go wrong
This is a Phase 2 trial, so results are preliminary. Vitamin A may not reduce GVHD, and high doses can have side effects like liver toxicity or increased intracranial pressure.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 190 people

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

Started

Mar 2025

Expected to finish

Aug 2029

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

18 years and older

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: * Be 18 years of age or older * Be scheduled for allogeneic stem cell transplant. * Have a vitamin A level \< upper limit of normal for age. * Be able to tolerate enteral vitamin dose administration. * Have a total bilirubin level \< 1.5x ULN and an AST and/or ALT\< 3xULN for age * Receiving PBSCs as stem cell graft Exclusion Criteria: * Ongoing raised intracranial pressure (see appendix D for definition of raised intracranial pressure) * Liver cirrhosis (see appendix C for definition of liver cirrhosis) * Patients will be excluded if they are currently pregnant. * Patients will be excluded if they have a fish (not shellfish) allergy.

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Conditions

The condition(s) this trial relates to.

graft versus host disease vitamin A deficiency vitamin D deficiency chronic graft versus host disease prevention target

As listed by the trial registrant

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

Graft-VS-host disease Vitamin A deficiency Vitamin D deficiency

How to take part

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

  1. The places running it

    3 sites. 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

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

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