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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Seoul National University
• Treatments: Cholecalciferol; Vitamin D

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