Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03320915
Other study ID # H-1702-040-830
Secondary ID
Status Recruiting
Phase Phase 2
First received October 22, 2017
Last updated October 22, 2017
Start date October 1, 2017
Est. completion date December 2019

Study information

Verified date October 2017
Source Seoul National University Hospital
Contact Jae Hyun Kim
Phone 82-2-2072-0335
Email jaerung90@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic GVHD Events will be graded according to IBMTR criteria Up to 1 year
Secondary Acute GVHD Events will be graded according to IBMTR criteria Up to 100 days
Secondary Vitamin D deficiency Severity and incidence of Vitamin D deficiency Up to 1 year
Secondary 25(OH)D3 Serum concentration of 25(OH)D3 Up to 1 year
See also
  Status Clinical Trial Phase
Completed NCT03483194 - Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care (REVEH) Phase 2/Phase 3
Recruiting NCT03735992 - Mind-body Medicine for Patients With Malignant Hematological Diseases N/A
Recruiting NCT04959175 - Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies Phase 1/Phase 2
Withdrawn NCT04275154 - Immunological Parameters, Neurocognitive Changes, Activity, & Driving Fitness in Patients Undergoing CAR-T Cell Therapy
Completed NCT00997386 - Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States Phase 2
Terminated NCT00957580 - Trial of Pimasertib in Hematological Malignancies Phase 2
Completed NCT00389428 - Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer. Phase 1
Completed NCT02193880 - Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT) N/A
Recruiting NCT00071045 - Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Not yet recruiting NCT05054231 - Immunological Profile for Patients Treated With CAR-T Cells N/A
Completed NCT02650791 - Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study Phase 3
Completed NCT01362179 - National Marrow Donor Program Long-Term Donor Follow-Up
Terminated NCT02900248 - CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
Terminated NCT03648372 - A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System Phase 1/Phase 2
Recruiting NCT06422533 - Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients N/A
Terminated NCT02895529 - A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy Phase 4
Active, not recruiting NCT03680092 - Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation Phase 2
Recruiting NCT03083327 - Prophylactic Early PN in HPT/BMT N/A
Recruiting NCT03743480 - Early Palliative Care and Hematological Cancer Patients N/A
Completed NCT02635984 - Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens Phase 3