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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03320915
• Other study ID #: H-1702-040-830
• Status: Recruiting
• Phase: Phase 2
• First received: October 22, 2017
• Last updated: October 22, 2017
• Start date: October 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: Jae Hyun Kim
• Phone: 82-2-2072-0335
• Email: jaerung90[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

Drug:
• Cholecalciferol
Cholecalciferol 5mg (200,000 IU) up to maximum of three times during 1 year follow-up period according to measured 25(OH)D3 level.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic GVHD	Events will be graded according to IBMTR criteria	Up to 1 year
Secondary	Acute GVHD	Events will be graded according to IBMTR criteria	Up to 100 days
Secondary	Vitamin D deficiency	Severity and incidence of Vitamin D deficiency	Up to 1 year
Secondary	25(OH)D3	Serum concentration of 25(OH)D3	Up to 1 year