A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation

Conditions
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Hematopoietic Stem Cell Transplant

Intervention / Treatment
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* Dietary Supplement: Vitamin D and A
* Dietary Supplement: Vitamin D and Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D and A Supplementation<br>Participants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT. | Dietary Supplement: Vitamin D and A<br>* A single dose of Vitamin A and Vitamin D will be given.<br>|
| Active Comparator: Vitamin D Supplementation with Placebo<br>Participants receive a single dose of vitamin D and a single dose of placebo prior to HSCT. | Dietary Supplement: Vitamin D and Placebo<br>* A single dose of Vitamin D plus a placebo will be given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 100 days after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MBI-LCBI | Incidence of MBI-LCBI at day +100 after transplant. | 100 days after transplant | 
| Treatment Related Mortality | Treatment related mortality at day +100 after transplant. | 100 days after transplant | 
| Overall Survival | Overall survival at 1 year after transplant. | 1 year after transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematopoietic stem cell transplant, vitamin a, vitamin d