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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03719092
Collaborator
(none)
34
Enrollment
1
Location
1
Arm
34.8
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin A Compound
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To assess the feasibility and safety of pre-transplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients until day +28 after transplant.

OUTLINE: This is a dose-escalation study.

Participants receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant.

After completion of study treatment, participants are followed up periodically.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Single, High Dose Vitamin A Replacement in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Feb 7, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prevention (vitamin A compound)

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
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

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [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 Outcome Measures

    1. Incidence of gastrointestinal graft versus host disease [Up to day 180 after stem cell transplant]

      Cumulative incidence of GI GVHD will be calculated and graphed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • Baseline pre-transplant Vitamin A levels higher than the upper quartile of normal range for age

    • 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

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Hannah Choe, MD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Hannah Choe, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03719092
    Other Study ID Numbers:
    • OSU-18078
    • NCI-2018-01838
    First Posted:
    Oct 25, 2018
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vitamins
    Vitamin A
    Retinol palmitate

    Study Results

    No Results Posted as of Apr 5, 2022