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

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ClinicalTrials.gov Identifier: NCT03320915
Recruitment Status : Unknown
Verified October 2017 by Youngil Koh, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Seoul National University
Information provided by (Responsible Party):
Youngil Koh, 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

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Drug: Cholecalciferol 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: Caldiferol

No Intervention: Usual care
Usual care



Primary Outcome Measures :
  1. Chronic GVHD [ Time Frame: Up to 1 year ]
    Events will be graded according to IBMTR criteria


Secondary Outcome Measures :
  1. Acute GVHD [ Time Frame: Up to 100 days ]
    Events will be graded according to IBMTR criteria

  2. Vitamin D deficiency [ Time Frame: Up to 1 year ]
    Severity and incidence of Vitamin D deficiency

  3. 25(OH)D3 [ Time Frame: Up to 1 year ]
    Serum concentration of 25(OH)D3



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320915


Contacts
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Contact: Jae Hyun Kim 82-2-2072-0335 jaerung90@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Youngil Koh, M.D.       go01@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University
Investigators
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Principal Investigator: Youngil Koh, M.D. Seoul National University Hospital
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Responsible Party: Youngil Koh, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03320915    
Other Study ID Numbers: H-1702-040-830
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents