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| Name | Class |
|---|---|
| Seoul National University | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Experimental | Cholecalciferol 5mg (200,000 IU) |
|
| Usual care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Cholecalciferol 5mg (200,000 IU) up to maximum of three times during 1 year follow-up period according to measured 25(OH)D3 level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic GVHD | Events will be graded according to IBMTR criteria | Up to 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Hyun Kim | Contact | 82-2-2072-0335 | jaerung90@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Youngil Koh, M.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Up to 1 year |
| 25(OH)D3 | Serum concentration of 25(OH)D3 | Up to 1 year |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |