Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03719092

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Vitamin A Compound

Dietary Supplement

Given PO or enterally

Other names: 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

Best Practice

Other

Receive usual care

Other names: Standard of care, standard therapy

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

    Time frame: Up to day 28

    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.

Secondary outcomes

  1. Incidence of gastrointestinal graft versus host disease

    Time frame: Up to day 180 after stem cell transplant

    Cumulative incidence of GI GVHD will be calculated and graphed.

  2. Incidence of Toxicity

    Time frame: Up to 28 days

    The toxicity analysis will include summarization of the toxicity and tolerability will be tabulated by dose level and summarized. Severe (grade 3+) toxicities will be summarized as well by type as well as in summary format of hematologic vs. non-hematologic severe toxicity incidence.

Other outcomes

  1. Compliance of Stool collection

    Time frame: Pre-transplant, day 0, day 14, and day 28

    Compliance rate of take-home kit completion and inpatient stool collection

  2. Stool microbe and vitamin A correlation

    Time frame: Pre-transplant, day 0, day 14, and day 28

    Correlation between stool microbes and response to vitamin A supplementation

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Oct 25, 2018
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.