A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 83
- Locations
- 2
- Primary Endpoint
- GI GVHD
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled for allogeneic stem cell transplant
- •Vitamin D level < 50 ng/ml
- •Vitamin A level < 75th centile for age
- •Able to tolerate enteral vitamin dose administration
Exclusion Criteria
- •History of pathologic fractures
- •Known history of nephrocalcinosis or nephrolithiasis
- •Current granulomatous disease
- •ALT > 10X ULN for age prior to administration of vitamin A
- •Ongoing raised intracranial pressure
- •Pregnancy
Outcomes
Primary Outcomes
GI GVHD
Time Frame: 100 days after transplant
Incidence of acute GI GVHD at day +100 after transplant. GVHD will be graded by the treating physician as per the modified Glucksberg criteria.
Secondary Outcomes
- MBI-LCBI(100 days after transplant)
- Treatment Related Mortality(100 days after transplant)
- Overall Survival(1 year after transplant)