RECRUITING

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

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.

Study Overview

Study Details

Study overview

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.

A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Condition
Graft Vs Host Disease
Intervention / Treatment

-

Contacts and Locations

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14203

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Medical Center, Cincinnati,

Pooja Khandelwal, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

2029-08