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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Heart transplanted patients treated with everolimus

Exclusion criteria

Treatment and study plan

Vitamin D

Dietary Supplement

Oral daily vitamin D

Primary outcomes

Oral daily everolimus dose change

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

The Effect of Normalizing Vitamin D Concentrations on Everlomius Trough Concentrations

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jan 18, 2018
Registry last updated: Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed