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

Phase 2

• Conditions: Hematologic Neoplasms
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT03320915
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Status Verified: 2017-10
• Study Start: 2017-10-01
• Study First Submitted: 2017-10-22
• Study First Submitted QC: 2017-10-22
• Last Update Submitted: 2017-10-22
• Study First Posted: 2017-10-25
• Last Update Posted: 2017-10-25
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol	Cholecalciferol	Cholecalciferol 5mg (200,000 IU)

Primary Outcome Measures

Name	Time	Method
Chronic GVHD	Up to 1 year	Events will be graded according to IBMTR criteria

Secondary Outcome Measures

Name	Time	Method
25(OH)D3	Up to 1 year	Serum concentration of 25(OH)D3
Acute GVHD	Up to 100 days	Events will be graded according to IBMTR criteria
Vitamin D deficiency	Up to 1 year	Severity and incidence of Vitamin D deficiency

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of