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NCT Number: NCT00785109

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

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

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Key information

Conditions

Aortic Valve Calcification Aortic Valve, Calcification of

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

Patients will be allocated to two groups with either

  • additional intake of 2 mg vitamin k1 daily
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K supplementation

Dietary Supplement

Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2

Primary outcomes

  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 outcomes

  1. progression of diastolic and systolic dysfunction in the three treatment groups

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Acronym: 08-002

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2008
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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