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A Randomized Double Blinded Trial of 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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Moffitt Cancer Center
Tampa, Florida, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
The Ohio State University
Columbus, Ohio, United States
Start Date
March 25, 2025
Primary Completion Date
August 1, 2027
Completion Date
August 1, 2029
Last Updated
August 12, 2025
190
ESTIMATED participants
Vitamin A
DRUG
Placebo
OTHER
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
NCT00106925
NCT03188796
Data Source & Attribution
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