Hematopoietic Stem Cell Transplant
Conditions
Keywords
hematopoietic stem cell transplant, vitamin a, vitamin d
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.
Interventions
DIETARY_SUPPLEMENTVitamin D and A
A single dose of Vitamin A and Vitamin D will be given.
DIETARY_SUPPLEMENTVitamin D and Placebo
A single dose of Vitamin D plus a placebo will be given.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI GVHD | 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
| Measure | Time frame | Description |
|---|---|---|
| MBI-LCBI | 100 days after transplant | Incidence of MBI-LCBI at day +100 after transplant. |
| Treatment Related Mortality | 100 days after transplant | Treatment related mortality at day +100 after transplant. |
| Overall Survival | 1 year after transplant | Overall survival at 1 year after transplant. |
Countries
United States
Outcome results
None listed