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New treatment option for Graft Vs Host Disease
Official title Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
ClinicalTrials.gov ID: NCT06450925
What this study is testing
What is Vitamin A?
Vitamin A is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for graft vs host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join 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
You likely can't join if
- Ongoing raised intracranial pressure
- Liver cirrhosis
- Patients will be excluded if they are currently pregnant.
See the full eligibility 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
- Ongoing raised intracranial pressure
- Liver cirrhosis
- Patients will be excluded if they are currently pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Buffalo, New York, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Buffalo, New York, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.