- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03320915
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT
October 22, 2017 updated by: Youngil Koh, Seoul National University Hospital
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing Hematopoietic Stem Cell Transplantation
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
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
88
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jae Hyun Kim
- Phone Number: 82-2-2072-0335
- Email: jaerung90@gmail.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
-
Contact:
- Youngil Koh, M.D.
- Email: go01@snu.ac.kr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
|
|
Experimental: Cholecalciferol
Cholecalciferol 5mg (200,000 IU)
|
Cholecalciferol 5mg (200,000 IU) up to maximum of three times during 1 year follow-up period according to measured 25(OH)D3 level.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic GVHD
Time Frame: Up to 1 year
|
Events will be graded according to IBMTR criteria
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute GVHD
Time Frame: Up to 100 days
|
Events will be graded according to IBMTR criteria
|
Up to 100 days
|
Vitamin D deficiency
Time Frame: Up to 1 year
|
Severity and incidence of Vitamin D deficiency
|
Up to 1 year
|
25(OH)D3
Time Frame: Up to 1 year
|
Serum concentration of 25(OH)D3
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Youngil Koh, M.D., Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
October 22, 2017
First Submitted That Met QC Criteria
October 22, 2017
First Posted (Actual)
October 25, 2017
Study Record Updates
Last Update Posted (Actual)
October 25, 2017
Last Update Submitted That Met QC Criteria
October 22, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-1702-040-830
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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