Effect of Vitamin D on Everolimus Trough Concentrations Among Heart Transplanted Patients
Not Applicable
Completed
- Conditions
- Vitamin D Deficiency
- Interventions
- Dietary Supplement: Vitamin D
- Registration Number
- NCT03403647
- Lead Sponsor
- Sheba Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
Heart transplanted patients treated with everolimus
Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D deficient Vitamin D Vitamin D supplementation and close everolimus trough levels monitoring with oral dose adjustments
- Primary Outcome Measures
Name Time Method Oral daily everolimus dose change 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Ramat Gan, Israel