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Vitamin
High Dose Vitamin A for Stem Cell Transplant Recipients
N/A
Recruiting
Led By Hannah Choe, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 180 after stem cell transplant
Awards & highlights
Study Summary
This trial is testing if high doses of vitamin A can help prevent gastrointestinal GVHD in people undergoing stem cell transplants.
Who is the study for?
This trial is for adults set to have a stem cell transplant from a donor who matches their human leukocyte antigen (HLA) or is slightly mismatched. They should be undergoing this procedure due to blood cancers and can have either intense or less intense pre-transplant treatments.Check my eligibility
What is being tested?
The study tests if high doses of vitamin A can prevent gastrointestinal problems after receiving a stem cell transplant from a donor. It's in the early stages, focusing on safety and how well it works to stop these complications.See study design
What are the potential side effects?
Potential side effects are not detailed here, but generally, high doses of vitamin A may cause headaches, dizziness, nausea, skin irritation, pain at the site of injection if given intravenously, and could potentially lead to liver damage with prolonged use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 180 after stem cell transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 180 after stem cell transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vitamin A
Secondary outcome measures
Incidence of gastrointestinal graft versus host disease
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prevention (vitamin A compound)Experimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,133 Total Patients Enrolled
Hannah Choe, MDPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
2 Previous Clinical Trials
272 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Prevention (vitamin A compound)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation still open to participants?
"Based on the information available, this research project is open to enrolment. It was opened for recruitment on February 7th 2020 and last updated March 24th 2022."
Answered by AI
What is the aggregate populace of participants included in this experiment?
"Affirmative. According to clinicaltrials.gov, this experiment is enrolling volunteers and was initially published on February 7th 2020 before being amended most recently on March 24th 2022. It's projected that 34 participants need to be recruited from one single site."
Answered by AI
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