An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
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
Liver cirrhosis
Patients will be excluded if they are currently pregnant.
Additional locations may be listed 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
