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

This study is currently recruiting participants.
Verified March 2013 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00785109
First received: November 4, 2008
Last updated: March 21, 2013
Last verified: March 2013
History of Changes

November 4, 2008
March 21, 2013
January 2010
December 2014   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00785109 on ClinicalTrials.gov Archive Site
progression of diastolic and systolic dysfunction in the three treatment groups [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2014
December 2014   (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
Both
50 Years and older
No
Contact: Ralf Koos, MD ++49 241 ext 8035624 rkoos@ukaachen.de
Germany
 
NCT00785109
Vitamin K Study, 2008-005306-39
No
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
March 2013

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