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

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ClinicalTrials.gov Identifier: NCT00785109
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Aortic Valve Calcification Dietary Supplement: Vitamin K supplementation Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
Study Start Date : January 2010
Primary Completion Date : August 2015
Study Completion Date : August 2015


Arms and Interventions

Arm Intervention/treatment
Experimental: 1
100 patients daily additional intake of 2mg vitamin k1
Dietary Supplement: Vitamin K supplementation
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
Placebo Comparator: 2
100 patients no additional intake of vitamin K
Dietary Supplement: Vitamin K supplementation
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. progression of diastolic and systolic dysfunction in the three treatment groups [ Time Frame: 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785109


Locations
Germany
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Ralf Koos, MD RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
More Information

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00785109     History of Changes
Other Study ID Numbers: Vitamin K Study
2008-005306-39
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017

Keywords provided by RWTH Aachen University:
aortic valve calcification
vitamin K supplementation

Additional relevant MeSH terms:
Calcinosis
Aortic Valve Stenosis
Calcium Metabolism Disorders
Metabolic Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Vitamins
Vitamin K
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants