RECRUITING

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-25
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06450925

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be 18 years of age or older
  2. * Be scheduled for allogeneic stem cell transplant.
  3. * Have a vitamin A level \< upper limit of normal for age.
  4. * Be able to tolerate enteral vitamin dose administration.
  5. * Have a total bilirubin level \< 1.5x ULN and an AST and/or ALT\< 3xULN for age
  6. * Receiving PBSCs as stem cell graft
  1. * Ongoing raised intracranial pressure
  2. * Liver cirrhosis
  3. * Patients will be excluded if they are currently pregnant.

Contacts and Locations

Study Contact

Celeste Dourson, MS, CCRP
CONTACT
513-636-7679
celeste.dourson@cchmc.org

Principal Investigator

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

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
United States
The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25
Study Completion Date2029-08

Study Record Updates

Study Start Date2025-03-25
Study Completion Date2029-08

Terms related to this study

Additional Relevant MeSH Terms

  • Graft Vs Host Disease
  • Vitamin A Deficiency
  • Vitamin D Deficiency