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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates

NCT03039257

Hematopoietic Stem Cell Transplant

COMPLETED NA

Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT

NCT03320915

Hematologic Neoplasms

UNKNOWN PHASE2

Donor Mesenchymal Stem Cell Infusion in Treating Patients With Acute or Chronic Graft-Versus-Host Disease After Undergoing a Donor Stem Cell Transplant

NCT00361049

Cancer

COMPLETED PHASE1

Collecting and Storing Tissue and DNA Samples From Patients Undergoing a Donor Stem Cell Transplant

NCT00900406

Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor +9 more

COMPLETED

Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation

NCT07315165

Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Cohort (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.

Group Type EXPERIMENTAL

Vitamin A Compound

Intervention Type DIETARY_SUPPLEMENT

Given PO or enterally

Control Cohort (usual care)

Patients receive usual care.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin A Compound

Given PO or enterally

Intervention Type DIETARY_SUPPLEMENT

Best Practice

Receive usual care

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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 Standard of care standard therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No