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CompletedNCT03403647Updated Apr 18, 2019

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

An interventional study of Vitamin D in Vitamin D Deficiency, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vitamin D Deficiency

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03

In context

Vitamin D Deficiency

784 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's enrollment of 11 is below the median of 77 across 574 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 677 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Heart transplanted patients treated with everolimus

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Vitamin D deficient

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

    Dietary Supplement: Vitamin D

  • No intervention
    No vitamin D deficiency

    Regular and routine monitoring

Interventions

  • Dietary supplementVitamin D

    Oral daily vitamin D

06

What researchers measure

Primary outcomes

  1. Oral daily everolimus dose change

    Time frame: 8 weeks

07

Study locations

1 site
  • Sheba Medical Center
    Ramat Gan, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03403647
Responsible party
Dr.Itai Gueta (Physician in the institute for clinical pharmacology, Sheba Medical Center) — Principal investigator
First posted
Jan 18, 2018
Start date
Jul 15, 2018
Primary completion
Apr 10, 2019
Completion
Apr 10, 2019
Last update
Apr 18, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin D

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