Vitamin D Deficiency Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 190 |
Est. completion date | August 2029 |
Est. primary completion date | August 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - History of ongoing raised intracranial pressure - History of pregnancy - History of liver cirrhosis |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Comprehensive Cancer Center | Buffalo | New York |
United States | The Ohio State University | Columbus | Ohio |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of moderate-severe chronic graft versus host disease (GVHD) | Incidence of moderate-severe chronic GVHD | 1 year after transplant | |
Secondary | Incidence of acute gastrointestinal graft versus host disease (GI GVHD) | Incidence of acute GI GVHD | 2 years after transplant | |
Secondary | Incidence of relapse | Incidence of relapse | 2 years after transplant | |
Secondary | Overall survival. | Overall survival. | 2 years after transplant |
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