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Vitamin a boost before stem cell transplant may shield the gut

NCT ID NCT03719092

Prevention Sponsor: Ohio State University Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether a single high dose of vitamin A, given before a donor stem cell transplant, can prevent gastrointestinal graft-versus-host disease (GVHD), a condition where donor cells attack the gut. Vitamin A deficiency is linked to a higher risk of this complication, and vitamin A helps intestinal cells grow and repair. The study enrolls adults with blood cancers who are scheduled for a transplant. Researchers will find a dose that safely raises vitamin A levels and then measure how many participants develop gut GVHD.

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 (retinol) given as a single high dose before transplant
What this could lead to
If it works, a simple vitamin A dose before transplant could reduce the risk of a serious gut complication, improving recovery for stem cell transplant patients.
What could go wrong
This is an early-phase trial, so the dose may not be safe or effective. Vitamin A can be toxic in high amounts, and the study is small, so results may not apply to everyone.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

62 people

The number who actually took part.

Started

Feb 2020

Finished

Oct 2025

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: * Adult patients planned to undergo an allogeneic stem cell transplant (SCT) with an human leukocyte antigen (HLA)-matched (unrelated or related) or 1 allele mismatched (7/8) donor or haploidentical donor who received either myeloablative or nonmyeloablative conditioning for hematologic malignancies are eligible Exclusion Criteria: * Vitamin A hypersensitivity or allergy * Abnormal liver enzymes outside of the institutional laboratory normal range within 30 days of screening * Abnormal total, indirect, or direct bilirubin outside of the institutional laboratory normal range within 30 days of screening * Enteral feeding intolerance * Medication intolerance - history of allergic reaction to Vitamin A or other history of discontinuation to study drug due to adverse effect * Pregnancy

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm graft versus host disease prevention target

As listed by the trial registrant

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

Allogeneic hematopoietic stem cell transplantation recipient

Contacts and locations

Locations

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

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