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

NCT ID: NCT03403647

Last Updated: 2019-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2019-04-10

Brief Summary

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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

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D deficient

Vitamin D supplementation and close everolimus trough levels monitoring with oral dose adjustments

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Oral daily vitamin D

No vitamin D deficiency

Regular and routine monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D

Oral daily vitamin D

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Heart transplanted patients treated with everolimus

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr.Itai Gueta

Physician in the institute for clinical pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Vitamin D and Everolimus

Identifier Type: -

Identifier Source: org_study_id

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