Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification (08-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00785109
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : April 21, 2017
Information provided by (Responsible Party):
RWTH Aachen University

November 4, 2008
November 5, 2008
April 21, 2017
January 2010
August 2015   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00785109 on Archive Site
progression of diastolic and systolic dysfunction in the three treatment groups [ Time Frame: 18 months ]
Same as current
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Not Provided
Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Aortic Valve Calcification
Dietary Supplement: Vitamin K supplementation
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
  • Experimental: 1
    100 patients daily additional intake of 2mg vitamin k1
    Intervention: Dietary Supplement: Vitamin K supplementation
  • Placebo Comparator: 2
    100 patients no additional intake of vitamin K
    Intervention: Dietary Supplement: Vitamin K supplementation
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2015
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Vitamin K Study
Not Provided
Not Provided
RWTH Aachen University
RWTH Aachen University
Not Provided
Principal Investigator: Ralf Koos, MD RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
RWTH Aachen University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP