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NCT03403647 Clinical Trial

Effect of Vitamin D on Everolimus Trough Concentrations Among Heart Transplanted Patients

Vitamin D Deficiency Clinical Trial

Official title:
The Effect of Normalizing Vitamin D Concentrations on Everlomius Trough Concentrations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03403647
Other study ID # Vitamin D and Everolimus
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2018
Est. completion date April 10, 2019

Study information
Verified date April 2019
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 11
Est. completion date April 10, 2019
Est. primary completion date April 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Heart transplanted patients treated with everolimus

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Vitamin D
Oral daily vitamin D

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oral daily everolimus dose change 8 weeks
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