Vitamin A for Graft-versus-Host Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byPooja Khandelwal, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Children's Hospital Medical Center, Cincinnati

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pooja Khandelwal, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

This trial is for people who are about to undergo a stem cell transplant, have lower than normal levels of Vitamin A, can take vitamins by mouth, and have liver function within certain limits. It's not for those with high brain pressure, pregnant individuals or anyone with liver cirrhosis.

Inclusion Criteria

Total bilirubin level < 1.5x ULN and AST and/or ALT < 3x ULN for age

I am scheduled for a stem cell transplant from a donor.

I can take vitamins by mouth without issues.

See 1 more

Exclusion Criteria

I have a history of increased pressure inside my skull.

History of pregnancy

I have a history of liver cirrhosis.

Treatment Details

Interventions

Vitamin A (Vitamin Supplement)

Trial OverviewThe study tests if taking a single high dose of Vitamin A orally can reduce the chances of developing moderate to severe chronic Graft-versus-Host Disease (GVHD) after a stem cell transplant compared to a placebo.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Vitamin AActive Control1 Intervention

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)

Group II: PlaceboPlacebo Group1 Intervention

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

Vitamin A is already approved in Canada for the following indications: