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

Aortic Valve Calcification Clinical Trial

— 08-002  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785109
• Other study ID #: Vitamin K Study
• Secondary ID: 2008-005306-39
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2008
• Last updated: April 20, 2017
• Start date: January 2010
• Est. completion date: August 2015

Study information

• Verified date: April 2017
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Calcification
• Aortic Valve Stenosis
• Calcinosis

Intervention

Dietary Supplement:
• Vitamin K supplementation
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2

Locations

Country	Name	City	State
Germany	Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K		18 months
Secondary	progression of diastolic and systolic dysfunction in the three treatment groups		18 months