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Vitamin Supplement

Vitamin A for Graft-versus-Host Disease

Phase 2

Waitlist Available

Led By Pooja Khandelwal, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for allogeneic stem cell transplant

Able to tolerate enteral vitamin dose administration

Must not have

History of ongoing raised intracranial pressure

History of liver cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year after transplant

Summary

"This trial aims to test if taking a high dose of vitamin A by mouth can lower the risk of a certain complication after a transplant compared to taking a placebo."

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include reactions similar to an overdose of vitamin A such as vision changes, bone pain or swelling, skin changes or discomfort in the stomach area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can take vitamins by mouth without issues.

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My Vitamin A levels are within the normal range for my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of increased pressure inside my skull.

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I have a history of liver cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year after transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year after transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of moderate-severe chronic graft versus host disease (GVHD)

Secondary study objectives

Incidence of acute gastrointestinal graft versus host disease (GI GVHD)

Incidence of relapse

Overall survival.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Vitamin AActive Control1 Intervention

Route of administration: oral/enteral. If an enteral tube is present the investigator may administer the dose via enteral tubes but will not specifically place enteral tubes solely for purposes of administering vitamin A. Frequency: Once. Timing: Pre-transplant Dose of Vit A: 4000 IU/kg, max dose 250,000 units. Formulation of Vit A: 10,000 IU 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 vegetable oil with lactose powder as a filler will be dispensed in patients who are randomized to the placebo arm.

0 / 5Eligibility criteria met