Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT

Study Overview
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Brief Summary
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Graft-versus-host-disease (GVHD) is common complication of hematopoietic stem cell transplantation. Vitamin D deficiency has been shown to be associated with increased risk of chronic GVHD in previous clinical studies. The purpose of this research is to investigate the effect of vitamin D supplementation in patients undergoing hematopoietic stem cell transplantation

Detailed Description
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Hematopoietic stem cell transplant candidates are randomized to vitamin D supplementation or usual care. Five milligrams (200,000 IU) of cholecalciferol is injected to intervention group before stem cell transplantation. Additional supplementation of cholecalciferol during follow-up period is determined according to the level of 25(OH)D3. The primary outcome is the incidence of chronic GVHD which is determined according to IBMTR criteria. The secondary outcome consists of the incidence of acute GVHD, incidence and severity of vitamin D deficiency, and serum concentration of 25(OH)D3. Study investigators expect that supplementation of vitamin D may improve the outcome of stem cell transplantation by reducing the incidence of chronic GVHD.

Official Title
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Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing Hematopoietic Stem Cell Transplantation

Conditions
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Hematologic Neoplasms

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with ≥ 18 years old Diagnosed with hematologic maligancies Planned to undergo allogeneic stem cell transplantation Exclusion Criteria: Hypercalcemia (ionized serum calcium level [iCa] > 1.3 mmol/L, corrected serum calcium level > 10.5 mg/dL) Impaired renal function (Serum creatinine ≥ 2.4 mg/dL) Not in complete remssion (except for myelodysplastic syndrome and myeloproliferative neoplasm) Consent withdrawal Considered inadequate under investigator's discretion

Ages Eligible for Study
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Minimum Age: 18 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholecalciferol<br>Cholecalciferol 5mg (200,000 IU) | Drug: Cholecalciferol<br>* Cholecalciferol 5mg (200,000 IU) up to maximum of three times during 1 year follow-up period according to measured 25(OH)D3 level.<br>* Other names: Caldiferol;|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic GVHD | Events will be graded according to IBMTR criteria | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute GVHD | Events will be graded according to IBMTR criteria | Up to 100 days | 
| Vitamin D deficiency | Severity and incidence of Vitamin D deficiency | Up to 1 year | 
| 25(OH)D3 | Serum concentration of 25(OH)D3 | Up to 1 year |