A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
Children's Hospital Medical Center, Cincinnati
Summary
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.
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 stu…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DrugVitamin 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.
- OtherPlacebo
Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.
Locations (3)
- Moffitt Cancer CenterTampa, Florida
- Roswell Park Comprehensive Cancer CenterBuffalo, New York
- The Ohio State UniversityColumbus, Ohio