An interventional study of Vitamin A Compound and Best Practice in Allogeneic Hematopoietic Stem Cell Transplantation Recipient, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
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.
Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Patients receive usual care.
Other: Best Practice
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
Receive usual care
Also known as: Standard of care, standard therapy
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.
Time frame: Up to day 28
Incidence of gastrointestinal graft versus host disease
Cumulative incidence of GI GVHD will be calculated and graphed.
Time frame: Up to day 180 after stem cell transplant
Incidence of Toxicity
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.
Time frame: Up to 28 days
Compliance of Stool collection
Compliance rate of take-home kit completion and inpatient stool collection
Time frame: Pre-transplant, day 0, day 14, and day 28
Stool microbe and vitamin A correlation
Correlation between stool microbes and response to vitamin A supplementation
Time frame: Pre-transplant, day 0, day 14, and day 28
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ohio State University Comprehensive Cancer Center