A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Moffitt Cancer Center
RECRUITING
Tampa
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Ohio
The Ohio State University
RECRUITING
Columbus
Contact Information
Primary
Celeste Dourson, MS, CCRP
celeste.dourson@cchmc.org
513-636-7679
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2029-08
Participants
Target number of participants: 190
Treatments
Active_comparator: Vitamin A
Route of administration: Oral. Frequency: Once. Timing: Pre-transplant Dose of Vit A: 1.2 mg/kg, max dose 75 mg Formulation of Vit A: 2.5 mg liquid filled oral capsules.~Vitamin A level assessment: Vitamin A levels will be measured pre-transplant and again at day +30 (± 10 days)
Placebo_comparator: Placebo
Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati