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

RWTH Aachen University99 enrolled

Overview

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

Patients will be allocated to two groups with either 1. additional intake of 2 mg vitamin k1 daily 2. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Calcification

Interventions

Vitamin K supplementationDIETARY_SUPPLEMENT

Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Aachen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K

Time frame: 18 months

Secondary Outcomes

progression of diastolic and systolic dysfunction in the three treatment groups

Time frame: 18 months

Data from ClinicalTrials.gov

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