NCT03719092

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. . To determine the biologically effective and tolerable dose (BETD) level of pretransplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients. SECONDARY OBJECTIVE: I. To evaluate the feasibility of collecting stool and profiling the gut microbiome in relation to Vitamin A. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 cohorts. TREATMENT COHORT: Patients receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant. Patients may receive vitamin A compound PO or enterally two weeks after stem cell transplant if vitamin A levels have not improved by at least 10%. CONTROL COHORT: Patients receive usual care. After completion of study treatment, participants are followed up periodically.

Conditions

• Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin A Compound	Given PO or enterally
OTHER	Best Practice	Receive usual care

Timeline

• Start date: 2020-02-07
• Primary completion: 2025-04-30
• Completion: 2026-12-31
• First posted: 2018-10-25
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States