Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Phase 2RecruitingNCT06450925

Children's Hospital Medical Center, Cincinnati190 enrolled

Overview

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.

Hematopoietic stem cell transplantation (HSCT) is an effective treatment strategy for many malignancies, marrow failure syndromes, and immune deficiencies in children, adolescents, and adults. Vitamin A and its derivatives regulate growth and differentiation of intestinal cells, and vitamin A deficiency is associated with increased susceptibility to infection in both human and animal models. The investigators' preliminary data suggest lower vitamin A levels were associated with an increased incidence of gastrointestinal graft versus host disease (GI GVHD) in patients undergoing HSCT. This study is a randomized double blinded comparison of vitamin A supplementation comparing a single large dose of vitamin A with a placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

190

Conditions

Graft Vs Host Disease Vitamin A Deficiency Vitamin D Deficiency

Interventions

Vitamin ADRUG

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.

PlaceboOTHER

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (3)

Moffitt Cancer Center

Tampa, Florida, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

RECRUITING

The Ohio State University

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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

Incidence of moderate-severe chronic GVHD

Time frame: 1 year after transplant

Secondary Outcomes

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

Incidence of acute GI GVHD

Time frame: 2 years after transplant

Incidence of relapse

Time frame: 2 years after transplant

Overall survival.

Time frame: 2 years after transplant

Central Contacts

Celeste Dourson, MS, CCRP

CONTACT

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

Data from ClinicalTrials.gov

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