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Recruiting Phase 2 NCT06450925
Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
Trial Parameters
Condition Graft Vs Host Disease
Sponsor Children's Hospital Medical Center, Cincinnati
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 190
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2025-03-25
Completion 2027-08
All Conditions
Interventions
Vitamin APlacebo
Brief 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 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 * Liver cirrhosis * Patients will be excluded if they are currently pregnant.
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