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

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ClinicalTrials.gov Identifier: NCT03719092
Recruitment Status : Not yet recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Hannah Choe, Ohio State University Comprehensive Cancer Center

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
Allogeneic Hematopoietic Stem Cell Transplantation Recipient Dietary Supplement: Vitamin A Compound Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
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
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arm Intervention/treatment
Experimental: Prevention (vitamin A compound)
Participants receive vitamin A compound PO or enterally once prior to stem cell transplant.
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




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 [ Time Frame: Up to day 28 ]

Secondary Outcome Measures :
  1. Incidence of gastrointestinal graft versus host disease [ Time Frame: Up to day 180 after stem cell transplant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719092


Contacts
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Contact: Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu
Contact: Rachel Dalton Rachel.Dalton@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Hannah Choe, MD    614-293-5428    Hannah.Choe@osumc.edu   
Principal Investigator: Hannah Choe, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Hannah Choe, MD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Hannah Choe, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03719092     History of Changes
Other Study ID Numbers: OSU-18078
NCI-2018-01838 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents