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

Hematologic Neoplasms Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03320915
Study type Interventional
Source Seoul National University Hospital
Contact Jae Hyun Kim
Phone 82-2-2072-0335
Email jaerung90@gmail.com
Status Recruiting
Phase Phase 2
Start date October 1, 2017
Completion date December 2019
View Details
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