Vitamin A Supplementation for Allogeneic Stem Cell Transplantation

This study is looking at whether a single dose of Vitamin A can help reduce a common complication called chronic graft-versus-host disease (GVHD) after an allogeneic stem cell transplant. GVHD happens when the new immune cells from the donor attack the patient's body. Researchers believe that Vitamin A, which helps with gut health, might lower the risk of this problem. You might be able to join if you are 18 or older, are scheduled for an allogeneic stem cell transplant, and have low vitamin A levels. The study will compare patients who receive Vitamin A to those who receive a placebo (an inactive pill). The main goal is to see if Vitamin A reduces moderate-to-severe chronic GVHD one year after your transplant. The current recruitment status is unclear.

Study design
This is a randomized, double-blinded study comparing Vitamin A to a placebo, with a planned enrollment of 190 participants.
What's involved
Enrolled subjects will receive one observed oral Vitamin A dose, prior to their hematopoietic stem cell transplant (HSCT), in the outpatient clinic or inpatient Bone Marrow Transplant (BMT) floor.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, incidence of moderate-severe chronic graft versus host disease (GVHD), is measured at 1 year after transplant.

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NCT06450925

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Recruiting
PHASE2Ages 18+InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~190 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Vitamin APlacebo

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of moderate-severe chronic graft versus host disease (GVHD)
Measured over 1 year after transplant
Graft Vs Host Disease
Vitamin A Deficiency
Vitamin D Deficiency
3 sites across 3 states
Florida1
New York1
Ohio1
  • Pooja Khandelwal, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

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Eligibility criteria

Inclusion

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

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.
  • Incidence of moderate-severe chronic graft versus host disease (GVHD)1 year after transplant

    Incidence of moderate-severe chronic GVHD