Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether taking a high dose of vitamin A can help prevent a condition called moderate-severe chronic graft-versus-host disease (GVHD) in patients who receive stem cell transplants. GVHD occurs when the donated cells recognize the patient’s body as foreign and attack it. Researchers believe that vitamin A may help reduce the chances of this happening. The trial is in the early stages and has not yet started recruiting participants.

To be eligible for this study, participants must be 18 years or older and scheduled for an allogeneic stem cell transplant, which means they will receive stem cells from a donor. They also need to have low levels of vitamin A and meet certain health criteria. Participants will receive either vitamin A or a placebo (a pill with no active ingredients) to compare the effects. It's important to note that individuals who are pregnant or have certain medical conditions, like liver cirrhosis or high pressure in the brain, will not be able to participate. This trial aims to provide valuable information that could improve the care of patients undergoing stem cell transplants.

Gender

ALL

Eligibility criteria

• 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.