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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03320915
Collaborator
Seoul National University (Other)
88
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Oct 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cholecalciferol

Cholecalciferol 5mg (200,000 IU)

Drug: Cholecalciferol
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:
  • Caldiferol

    		•
    No Intervention: Usual care

    Usual care

    Outcome Measures

    Primary Outcome Measures

    1. Chronic GVHD [Up to 1 year]

      Events will be graded according to IBMTR criteria

    Secondary Outcome Measures

    1. Acute GVHD [Up to 100 days]

      Events will be graded according to IBMTR criteria

    2. Vitamin D deficiency [Up to 1 year]

      Severity and incidence of Vitamin D deficiency

    3. 25(OH)D3 [Up to 1 year]

      Serum concentration of 25(OH)D3

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital
    • Seoul National University

    Investigators

    • Principal Investigator: Youngil Koh, M.D., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Youngil Koh, Principal Investigator, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03320915
    Other Study ID Numbers:
    • H-1702-040-830
    First Posted:
    Oct 25, 2017
    Last Update Posted:
    Oct 25, 2017
    Last Verified:
    Oct 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hematologic Neoplasms
    Cholecalciferol
    Vitamin D

    Study Results

    No Results Posted as of Oct 25, 2017