Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
Children's Hospital Medical Center, Cincinnati
190 participants
Mar 25, 2025
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria3
- Ongoing raised intracranial pressure
- Liver cirrhosis
- Patients will be excluded if they are currently pregnant.
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Interventions
Enrolled subjects will receive one observed oral vitamin A dose, prior to their HSCT, in the outpatient clinic or inpatient Bone Marrow Transplant (BMT) floor.
Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06450925