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

NCT03719092 | Active Not Recruiting DMC

• 2 other identifiers: OSU-18078NCI-2018-01838
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Outcome Measures

Primary Outcomes (1)

• Vitamin A dose that achieves level in the upper quartile of normal range for sex in at least 2/3 cases without dose limiting toxicity

  Determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients. determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients.

  Up to day 28

Secondary Outcomes (2)

• Incidence of gastrointestinal graft versus host disease

  Up to day 180 after stem cell transplant

• Incidence of Toxicity

  Up to 28 days

Other Outcomes (2)

• Compliance of Stool collection

  Pre-transplant, day 0, day 14, and day 28

• Stool microbe and vitamin A correlation

  Pre-transplant, day 0, day 14, and day 28

Study Arms (2)

Treatment Cohort (vitamin A compound)

EXPERIMENTAL

Participants receive vitamin A compound PO or enterally once prior to stem cell transplant. once over a given 24 hour period with or without food. We will re-dose at 2000 IU/kg (maximum 120,000 IU) if Week 2 Vitamin A levels remain within 10% of baseline Vitamin A.

Dietary Supplement: Vitamin A Compound

Control Cohort (usual care)

ACTIVE COMPARATOR

Patients receive usual care.

Other: Best Practice

Interventions

Vitamin A Compound DIETARY_SUPPLEMENT

Given PO or enterally

Also known as: A 313, Anti-Infective Vitamin, Antixerophthalmic Vitamin, Aquasol A, Arovit, Avibon, Avitol, Axerol, Axerophthol, Axerophtholum, Biosterol, Biovit-A, Del-Vi-A, Ido A 50, Idrurto A, Lard Factor, Lard-Factor, Ledovit A, Micelle A, Mulsal A Megadosis, Oleovitamin A, Ophthalamin, Pedi-Vit-A, Retinol, all trans-, Rinocusi Vitaminico, Vitamin A, Vitamin A Alcohol, Vitamin A USP, Vitamin A1, Vitaminoftalmina, Vitaminum A, Vogan

Treatment Cohort (vitamin A compound)

Best Practice OTHER

Receive usual care

Also known as: Standard of care, standard therapy

Control Cohort (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients planned to undergo an allogeneic stem cell transplant (SCT) with an human leukocyte antigen (HLA)-matched (unrelated or related) or 1 allele mismatched (7/8) donor or haploidentical donor who received either myeloablative or nonmyeloablative conditioning for hematologic malignancies are eligible

You may not qualify if:

• Vitamin A hypersensitivity or allergy
• Abnormal liver enzymes outside of the institutional laboratory normal range within 30 days of screening
• Abnormal total, indirect, or direct bilirubin outside of the institutional laboratory normal range within 30 days of 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Vitamin A; Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Hannah Choe, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: February 7, 2020
• Primary Completion: April 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)