High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant
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- STATUS
- Recruiting
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- End date
- Dec 31, 2022
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- participants needed
- 34
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- sponsor
- Ohio State University Comprehensive Cancer Center
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 Identifier | NCT03719092 |
| Sponsor | Ohio State University Comprehensive Cancer Center |
| Last Modified on | 26 April 2022 |
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