RecruitingPhase 2

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

United States190 participantsStarted 2025-03-25

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of moderate-severe chronic graft versus host disease (GVHD)

Timeframe: 1 year after transplant

Trial details

NCT IDNCT06450925

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Celeste Dourson, MS, CCRP

513-636-7679 celeste.dourson@cchmc.org

View on ClinicalTrials.gov More Graft Vs Host Disease trials