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Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

RecruitingPhase 2

A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.

What is being tested

Sponsor: Children's Hospital Medical Center, Cincinnati · Participants: 190 · Started: Mar 25, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06450925

Locations in the U.S.

FloridaMoffitt Cancer Center, Tampa
New YorkRoswell Park Comprehensive Cancer Center, Buffalo
OhioThe Ohio State University, Columbus

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.