Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Graft Vs Host Disease, Vitamin A Deficiency, Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT06450925

Run by

Children's Hospital Medical Center, Cincinnati

People needed

190

Starts

2025-03-25

Expected to finish

2029-08-01

Last updated by the study team

2025-08-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Ongoing raised intracranial pressure
• Liver cirrhosis
• Patients will be excluded if they are currently pregnant.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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