Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin A, Placebo.
- Who it may be relevant to
- Registry conditions: Graft Vs Host Disease, Vitamin A Deficiency, Vitamin D Deficiency. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
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.
Detailed description
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.
Interventions
- Drug 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. - Other Placebo
Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.
Primary outcome measures
- Incidence of moderate-severe chronic graft versus host disease (GVHD) [Time frame: 1 year after transplant]
Secondary outcome measures (3)
- Incidence of acute gastrointestinal graft versus host disease (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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Moffitt Cancer Center — Tampa
- Roswell Park Comprehensive Cancer Center — Buffalo
- The Ohio State University — Columbus
Identifiers
NCT: NCT06450925 · 2023-0301