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

Information source: RWTH Aachen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aortic Valve Calcification

Intervention: Vitamin K supplementation (Dietary Supplement)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: RWTH Aachen University

Official(s) and/or principal investigator(s):
Ralf Koos, MD, Principal Investigator, Affiliation: RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: progression of diastolic and systolic dysfunction in the three treatment groups

Detailed description: 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.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Aachen, NRW 52074, Germany
Additional Information

Starting date: January 2010
Last updated: November 4, 2014

Page last updated: August 23, 2015

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