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NCT Number: NCT06450925

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

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.

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Key information

Conditions

Graft vs Host Disease Avitaminosis Deficiency Diseases Immune System Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin A Deficiency Vitamin D Deficiency

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin A

Drug

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

Other

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

Primary outcomes

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

    Time frame: 1 year after transplant

    Incidence of moderate-severe chronic GVHD

Secondary outcomes

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

    Time frame: 2 years after transplant

    Incidence of acute GI GVHD

  2. Incidence of relapse

    Time frame: 2 years after transplant

    Incidence of relapse

  3. Overall survival.

    Time frame: 2 years after transplant

    Overall survival.

Study contacts

Contact information is provided by the study sponsor or research team.

Celeste Dourson, MS, CCRP

CONTACT

[email protected]

513-636-7679

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jun 10, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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