Status:
UNKNOWN
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 c...
Eligibility Criteria
Inclusion
- Adults with ≥ 18 years old
- Diagnosed with hematologic maligancies
- Planned to undergo allogeneic stem cell transplantation
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03320915
Start Date
October 1 2017
End Date
December 1 2019
Last Update
October 25 2017
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080