Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT
1 other identifier
interventional
88
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 22, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 25, 2017
October 1, 2017
1.2 years
October 22, 2017
October 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Chronic GVHD
Events will be graded according to IBMTR criteria
Up to 1 year
Secondary Outcomes (3)
Acute GVHD
Up to 100 days
Vitamin D deficiency
Up to 1 year
25(OH)D3
Up to 1 year
Study Arms (2)
Cholecalciferol
EXPERIMENTALCholecalciferol 5mg (200,000 IU)
Usual care
NO INTERVENTIONUsual care
Interventions
Cholecalciferol 5mg (200,000 IU) up to maximum of three times during 1 year follow-up period according to measured 25(OH)D3 level.
Eligibility Criteria
You may qualify if:
- Adults with ≥ 18 years old
- Diagnosed with hematologic maligancies
- Planned to undergo allogeneic stem cell transplantation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Seoul National Universitycollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youngil Koh, M.D.
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 22, 2017
First Posted
October 25, 2017
Study Start
October 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
October 25, 2017
Record last verified: 2017-10