Recruiting
Phase 2

Vitamin A

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06450925

Conditions

Graft Vs Host Disease

Vitamin A Deficiency

Vitamin D Deficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitamin A

Placebo

Study Details

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.

Conditions

Graft Vs Host Disease

Vitamin A Deficiency

Vitamin D Deficiency

Study ID

NCT06450925

Start date

Mar 25, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 (see appendix D for definition of raised intracranial pressure)
  • Liver cirrhosis (see appendix C for definition of liver cirrhosis)
  • Patients will be excluded if they are currently pregnant.
  • Patients will be excluded if they have a fish (not shellfish) allergy.

Study Design

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Vitamin A

Route 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 comparator: Placebo

Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.

Interventions

Vitamin A

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

Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.

Primary outcome measure

  • Incidence of moderate-severe chronic graft versus host disease (GVHD) [ Time Frame: 1 year after transplant ]

Central Contacts and Locations

Central contacts

Celeste Dourson, MS, CCRP

513-636-7679celeste.dourson@cchmc.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Nelli Bejanyan, MD

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14203

Principal Investigator:

Theresa Hahn, PhD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Sumithira Vasu, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-08-24.