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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
- Vitamin A (drug)
- Placebo (other)
Sponsor: Children's Hospital Medical Center, Cincinnati · Participants: 190 · Started: Mar 25, 2025
Contact the study team
- Celeste Dourson, MS, CCRP · Phone: 513-636-7679
Official record on ClinicalTrials.gov — NCT06450925
Locations in the U.S.
| Florida | Moffitt Cancer Center, Tampa |
| New York | Roswell Park Comprehensive Cancer Center, Buffalo |
| Ohio | The 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.