NCT06450925 · Children's Hospital Medical Center, Cincinnati
Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
What this study is about
The investigators hypothesize that single taken by mouth high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.
View original scientific description
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.
Interventions
DRUG
Vitamin A
Enrolled subjects will receive one observed oral vitamin A dose, prior to their HSCT, in the outpatient clinic or inpatient Bone Marrow Transplant (BMT) floor.
OTHER
Placebo
Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.
Primary outcome measures
Incidence of moderate-severe chronic graft versus host disease (GVHD)
Time frame: 1 year after transplant
Incidence of moderate-severe chronic GVHD
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Tampa, Florida
- Buffalo, New York
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2025 · Source of record for eligibility and locations