ACTIVE_NOT_RECRUITING

High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant

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Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Recipient

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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

This phase I trial studies the side effects and how well high dose vitamin A works in preventing gastrointestinal graft versus host disease (GVHD) in participants undergoing donor stem cell transplant. Vitamin A deficiency is associated with increased risk of gastrointestinal GVHD. Vitamin A regulates growth and differentiation of intestinal cells and may reduce risk of gastrointestinal GVHD.

Official Title

Single, High Dose Vitamin A Replacement in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Quick Facts

Study Start:2020-02-07
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03719092

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients planned to undergo an allogeneic stem cell transplant (SCT) with an human leukocyte antigen (HLA)-matched (unrelated or related) or 1 allele mismatched (7/8) donor or haploidentical donor who received either myeloablative or nonmyeloablative conditioning for hematologic malignancies are eligible
  1. * Vitamin A hypersensitivity or allergy
  2. * Abnormal liver enzymes outside of the institutional laboratory normal range within 30 days of screening
  3. * Abnormal total, indirect, or direct bilirubin outside of the institutional laboratory normal range within 30 days of screening
  4. * Enteral feeding intolerance
  5. * Medication intolerance - history of allergic reaction to Vitamin A or other history of discontinuation to study drug due to adverse effect
  6. * Pregnancy

Contacts and Locations

Principal Investigator

Hannah Choe, MD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Hannah Choe, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

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 Date2020-02-07
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-02-07
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Allogeneic Hematopoietic Stem Cell Transplantation Recipient