Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
1 other identifier
interventional
190
1 country
3
Brief Summary
The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2025
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2024
CompletedFirst Posted
Study publicly available on registry
June 10, 2024
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
August 12, 2025
August 1, 2025
2.4 years
June 5, 2024
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of moderate-severe chronic graft versus host disease (GVHD)
Incidence of moderate-severe chronic GVHD
1 year after transplant
Secondary Outcomes (3)
Incidence of acute gastrointestinal graft versus host disease (GI GVHD)
2 years after transplant
Incidence of relapse
2 years after transplant
Overall survival.
2 years after transplant
Study Arms (2)
Vitamin A
ACTIVE COMPARATORRoute of administration: Oral. Frequency: Once. Timing: Pre-transplant Dose of Vit A: 1.2 mg/kg, max dose 75 mg Formulation of Vit A: 2.5 mg liquid filled oral capsules. Vitamin A level assessment: Vitamin A levels will be measured pre-transplant and again at day +30 (± 10 days)
Placebo
PLACEBO COMPARATORPlacebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.
Interventions
Enrolled subjects will receive one observed oral vitamin A dose, prior to their HSCT, in the outpatient clinic or inpatient Bone Marrow Transplant (BMT) floor.
Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.
Eligibility Criteria
You may qualify if:
- Be 18 years of age or older
- Be scheduled for allogeneic stem cell transplant.
- Have a vitamin A level \< upper limit of normal for age.
- Be able to tolerate enteral vitamin dose administration.
- Have a total bilirubin level \< 1.5x ULN and an AST and/or ALT\< 3xULN for age
- Receiving PBSCs as stem cell graft
You may not qualify if:
- Ongoing raised intracranial pressure
- Liver cirrhosis
- Patients will be excluded if they are currently pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
The Ohio State University
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pooja Khandelwal, MD
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2024
First Posted
June 10, 2024
Study Start
March 25, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2029
Last Updated
August 12, 2025
Record last verified: 2025-08