Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification

Study Overview
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Brief Summary
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In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated. This will be done by means of measurements of concentrations from osteocalcine and MPG in blood serum, echocardiography, cardiac computed tomography and cardiac MRI

Detailed Description
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Patients will be allocated to two groups with either additional intake of 2 mg vitamin k1 daily controll group without additional intake of Vitamin K Treatment group a will include 100 patients, the controll group should include 100 patients. None of all patients should require renal dialysis.

Official Title
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Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process

Conditions
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Aortic Valve Calcification

Intervention / Treatment
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* Dietary Supplement: Vitamin K supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aortic valve calcification,verified by echocardiography Exclusion Criteria: chronic or acute intestinal diseases terminal renal failure allergic reaction on soya containing products recent additional intake of vitamin K oral anticoagulation with vitamin K antagonists (Marcoumar) systemic therapy with corticosteroids anamnestic venous thrombosis (pelvet or legs)or embolization of lung arteria pregnant or breastfeeding women persons without mental ability or capacity to understand and follow the instructions of the investigator women of childbearing age without safe contraceptional devices minority

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>100 patients daily additional intake of 2mg vitamin k1 | Dietary Supplement: Vitamin K supplementation<br>* Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2<br>|
| Placebo Comparator: 2<br>100 patients no additional intake of vitamin K | Dietary Supplement: Vitamin K supplementation<br>* Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression of diastolic and systolic dysfunction in the three treatment groups |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve calcification, vitamin K supplementation