Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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
Qualifiers
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.
Disqualifiers
Ongoing raised intracranial pressure
Liver cirrhosis
Patients will be excluded if they are currently pregnant.
Trial design
Treatments tested in this trial
- Vitamin A
- Placebo
Treatment groups
190 Participants
are divided into 2 treatment groupsLocations
3Moffitt Cancer Center33612, TampaFlorida, United States
Roswell Park Comprehensive Cancer Center14203, BuffaloNew York, United States
The Ohio State University43210, ColumbusOhio, United States
Sponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Source ClinicalTrials.gov