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Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

RecruitingPhase 2Ages 18 Years - anyAllChildren's Hospital Medical Center, Cincinnati
NCT06450925 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vitamin A
  • Placebo
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Where

3 sites
Moffitt Cancer Center
Tampa, United States
Roswell Park Comprehensive Cancer Center
Buffalo, United States
The Ohio State University
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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