Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT03719092
Brief 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.
Study:
NCT03719092
Study Brief:
Protocol Section:
NCT03719092