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

  • STATUS
    Recruiting
  • participants needed
    34
  • sponsor
    Ohio State University Comprehensive Cancer Center
Updated on 7 February 2023

Summary

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.

Description

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of pre-transplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients until day +28 after transplant.

OUTLINE: This is a dose-escalation study.

Participants receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant.

After completion of study treatment, participants are followed up periodically.

Details
Condition Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Treatment Vitamin A Compound
Clinical Study IdentifierNCT03719092
SponsorOhio State University Comprehensive Cancer Center
Last Modified on7 February 2023

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