High dose vitamin A to prevent gastrointestinal GVHD in stem cell transplant patients
Single, High Dose Vitamin a Replacement in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
NA · Ohio State University Comprehensive Cancer Center · NCT03719092
This study is testing if high doses of vitamin A can help prevent gastrointestinal problems in adults getting stem cell transplants.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT03719092 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of high dose vitamin A in preventing gastrointestinal graft versus host disease (GVHD) in adults undergoing donor stem cell transplants. It aims to determine the biologically effective and tolerable dose of vitamin A supplementation prior to transplantation. Participants are divided into treatment and control cohorts, with the treatment group receiving vitamin A and the control group receiving standard care. Additionally, the study evaluates the feasibility of profiling the gut microbiome in relation to vitamin A levels.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for an allogeneic stem cell transplant with a suitable donor match.
Not a fit: Patients with a history of vitamin A hypersensitivity or those with abnormal liver function tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of gastrointestinal GVHD in stem cell transplant recipients.
How similar studies have performed: While the use of vitamin A in this context is novel, previous studies have indicated that vitamin A deficiency is linked to increased GVHD risk, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Hannah Choe, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation Recipient