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Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
Trial Status: active
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.
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 (see appendix D for definition of raised intracranial pressure)
Liver cirrhosis (see appendix C for definition of liver cirrhosis)
Patients will be excluded if they are currently pregnant.
Patients will be excluded if they have a fish (not shellfish) allergy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06450925.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
New York
Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
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.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationCincinnati Children's Hospital Medical Center
