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

StatusCompleted
PhaseNot applicable
Started2020-02-07
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
Study Status, Oversight, Document Section v6
Trial completed
Study completion confirmed: October 2025 (last estimated December 2026)
Completion dateestimated 2026-12-31→confirmed 2025-10-19
2025-07-08
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2026-12-31→confirmed 2025-04-30
Enrollment targetestimated 130→confirmed 62
Study sitesdetails revised at 1 of 1 site
Study titlerevised
High Dose Vitamin aA in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant
2025-01-02
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Primary completion date2023-12-31→2026-12-31
Completion date2023-12-31→2026-12-31
Enrollment target34→130
Study arms1→2
InterventionsVitamin A Compound (Dietary Supplement)→Best Practice (Other), Vitamin A Compound (Dietary Supplement)
Eligibility criteria+20 characters
[...] e Exclusion Criteria: Vitamin A hypersensitivity or allergy Baseline pre-transplant Vitamin A levels higher than the upper quartile of normal range for age Abnormal liver enzymes outside of the institutional laborato [...] screening Enteral feeding intolerance Medication intolerance - history of allergic reaction to Vitamin A or other history of discontinuation to study drug due to adverse effect Pregnancy
Secondary endpoints1 to 2 entries
Incidence of Toxicity
Study description+384 characters
PRIMARY OBJECTIVES: I. . To assessdetermine the feasibilitybiologically effective and safetytolerable dose (BETD) level of pre-transplantpretransplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients until day +28 after transplant. 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. ParticipantsPatients are assigned to 1 of 2 cohorts. TREATMENT COHORT: Patients receive vitamin A compound orally (PO) or enterally once prior to st [...] [...]
Study sitescontacts updated at 1 of 1 site
Study titlerevised
High Dose Vitamin Aa in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant
2023-05-10
Study Status v3
Primary completion date2022-12-31→2023-12-31
Completion date2022-12-31→2023-12-31
2022-03-24
Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measures v2
Primary completion date2021-12-31→2022-12-31
Completion date2021-12-31→2022-12-31
Enrollment target28→34
Secondary endpointsdetails revised at 1 of 1 entry
Collaborators-31 characters
National Cancer Institute (NCI)
2021-02-25
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-12-01→confirmed 2020-02-07
Study sitesdetails revised at 1 of 1 site
2018-10-23
Original filing
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.
Trial Details
NCT Number NCT03719092
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Enrollment 62 participants
Start Date 2020-02-07
Primary Completion 2025-04-30 (estimated)
Study Completion 2025-10-19 (estimated)
Updated on ClinicalTrials.gov 2026-09-02