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

The Effect of Normalizing Vitamin D Concentrations on Everlomius Trough Concentrations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03403647
Enrollment
11
Registered
2018-01-18
Start date
2018-07-15
Completion date
2019-04-10
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTVitamin D

Oral daily vitamin D

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Heart transplanted patients treated with everolimus

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Oral daily everolimus dose change8 weeks

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026