Back to resultsEffect of Vitamin D on Everolimus Trough Concentrations Among Heart Transplanted Patients
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
Heart transplanted patients treated with everolimus
Exclusion Criteria:
-
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitamin D deficient
No vitamin D deficiency
Arm Description
Vitamin D supplementation and close everolimus trough levels monitoring with oral dose adjustments
Regular and routine monitoring
Outcomes
Primary Outcome Measures
Oral daily everolimus dose change
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03403647
Brief Title
Effect of Vitamin D on Everolimus Trough Concentrations Among Heart Transplanted Patients
Official Title
The Effect of Normalizing Vitamin D Concentrations on Everlomius Trough Concentrations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Vitamin D is part of the regular treatment regimen among patients after heart transplantation. Due to potential drug-drug interaction between vitamin D and everolmus, these patients are in increased risk for increased everolimus metabolism, potentially leading to under- immunosupression.
Detailed Description
post heart transplantation patients treated with everolimus will be screened for vitamin D levels. Patients defined as deficient will be treated with vitamin D with close and intensive monitoring everolimus levels, adjusting oral daily dose to maintain therapeutic levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D deficient
Arm Type
Experimental
Arm Description
Vitamin D supplementation and close everolimus trough levels monitoring with oral dose adjustments
Arm Title
No vitamin D deficiency
Arm Type
No Intervention
Arm Description
Regular and routine monitoring
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Oral daily vitamin D
Primary Outcome Measure Information:
Title
Oral daily everolimus dose change
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heart transplanted patients treated with everolimus
Exclusion Criteria:
-
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Effect of Vitamin D on Everolimus Trough Concentrations Among Heart Transplanted Patients
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