Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2029-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Graft Vs Host Disease Vitamin A Deficiency Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Vitamin A

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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