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

Primary Purpose

Hematologic Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cholecalciferol

Usual care

Arm Description

Cholecalciferol 5mg (200,000 IU)

Usual care

Outcomes

Primary Outcome Measures

Chronic GVHD
Events will be graded according to IBMTR criteria

Secondary Outcome Measures

Acute GVHD
Events will be graded according to IBMTR criteria
Vitamin D deficiency
Severity and incidence of Vitamin D deficiency
25(OH)D3
Serum concentration of 25(OH)D3

Full Information

First Posted
October 22, 2017
Last Updated
October 22, 2017
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University
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1. Study Identification

Unique Protocol Identification Number
NCT03320915
Brief Title
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT
Official Title
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Experimental
Arm Description
Cholecalciferol 5mg (200,000 IU)
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Caldiferol
Intervention Description
Cholecalciferol 5mg (200,000 IU) up to maximum of three times during 1 year follow-up period according to measured 25(OH)D3 level.
Primary Outcome Measure Information:
Title
Chronic GVHD
Description
Events will be graded according to IBMTR criteria
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Acute GVHD
Description
Events will be graded according to IBMTR criteria
Time Frame
Up to 100 days
Title
Vitamin D deficiency
Description
Severity and incidence of Vitamin D deficiency
Time Frame
Up to 1 year
Title
25(OH)D3
Description
Serum concentration of 25(OH)D3
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hyun Kim
Phone
82-2-2072-0335
Email
jaerung90@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngil Koh, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youngil Koh, M.D.
Email
go01@snu.ac.kr

12. IPD Sharing Statement

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

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