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

Sheba Medical Center

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT03403647

Vitamin D and Everolimus

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Heart transplanted patients treated with everolimus

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Vitamin D deficient

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D

No vitamin D deficiency

No Intervention group

Description:

Regular and routine monitoring