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

April 17, 2019 updated by: Dr.Itai Gueta, Sheba Medical Center

The Effect of Normalizing Vitamin D Concentrations on Everlomius Trough Concentrations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Heart transplanted patients treated with everolimus

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vitamin D deficient
Vitamin D supplementation and close everolimus trough levels monitoring with oral dose adjustments
Dietary supplement: Vitamin D
Oral daily vitamin D
NO_INTERVENTION: No vitamin D deficiency
Regular and routine monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oral daily everolimus dose change
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2018

Primary Completion (ACTUAL)

April 10, 2019

Study Completion (ACTUAL)

April 10, 2019

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (ACTUAL)

January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin D and Everolimus

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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