NCT06450925 Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
| NCT ID | NCT06450925 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Graft Vs Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 190 participants in total. It began in 2025-03-25 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Ongoing raised intracranial pressure * Liver cirrhosis * Patients will be excluded if they are currently pregnant.
Contact & Investigator
Pooja Khandelwal, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT06450925 clinical trial?
This trial is open to participants of all sexes, studying Graft Vs Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06450925 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06450925 currently recruiting?
Yes, NCT06450925 is actively recruiting participants. Contact the research team at celeste.dourson@cchmc.org for enrollment information.
Where is the NCT06450925 trial being conducted?
This trial is being conducted at Tampa, United States, Buffalo, United States, Columbus, United States.
Who is sponsoring the NCT06450925 clinical trial?
NCT06450925 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Pooja Khandelwal, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 190 participants.