The investigators hypothesize that supplementation with vitamins A and D will reduce the incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with supplementation with vitamin D alone.
The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) and they believe supplemental vitamin A at the time of hematopoietic stem cell transplantation (HSCT) can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). In addition, the investigators' preliminary data suggest that a significant number of patients requiring HSCT have vitamin D deficiency even prior to transplantation, and that persistent and newly developed deficiency post-HSCT resulted in worse outcomes. This study is a comparison of vitamin D supplementation comparing a single large dose of vitamin D "stoss therapy" with a placebo in the standard care arm with supplementation with single large doses of both vitamins D and A in the experimental arm. Participants will be randomly assigned to either the standard care arm or the experimental arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
83
A single dose of Vitamin A and Vitamin D will be given.
A single dose of Vitamin D plus a placebo will be given.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
GI GVHD
Incidence of acute GI GVHD at day +100 after transplant. GVHD will be graded by the treating physician as per the modified Glucksberg criteria.
Time frame: 100 days after transplant
MBI-LCBI
Incidence of MBI-LCBI at day +100 after transplant.
Time frame: 100 days after transplant
Treatment Related Mortality
Treatment related mortality at day +100 after transplant.
Time frame: 100 days after transplant
Overall Survival
Overall survival at 1 year after transplant.
Time frame: 1 year after transplant
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