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The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification (VitaK-CAC)

This study is currently recruiting participants.
Verified March 2016 by Maastricht University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01002157
First Posted: October 27, 2009
Last Update Posted: March 22, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
VitaK
Information provided by (Responsible Party):
Maastricht University Medical Center
  Purpose
Both Coronary Artery Calcification (CAC)and its annual progression are a strong predictors of cardiovascular events. The development of arterial calcification results from imbalance between calcification promoting and inhibiting factors. An important inhibitor of calcification is Matrix Gla Protein (MGP): a protein present in the vascular wall where it is synthesized by Vascular Smooth Muscle Cells (VSMC). MGP requires Vitamin K-mediated carboxylation to function properly. Deficiency of Vitamin K has been demonstrated to cause arterial calcification and a diet containing large amounts of Vitamin K2 was associated with lower CAC and cardiovascular risk. In animal studies, active supplementation of Vitamin K2 caused regression of existing arterial calcification. Therefore, the aim of this randomized, double-blind, placebo-controlled clinical trial is to investigate whether daily supplementation of Vitamin K2 (Menaquinone-7) to patients with established CAC will lead to a decreased progression-rate of CAC after 24 months of follow-up in comparison to placebo.

Condition Intervention
Coronary Artery Disease Dietary Supplement: Menaquinone-7 (Vitamin K2) Other: Placebo capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Coronary Artery Calcification-score progression [ Time Frame: 12 and 24 months ]

Secondary Outcome Measures:
  • Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity [ Time Frame: 0, 12 and 24 months ]
  • Carotid Intima Media Thickness [ Time Frame: 0, 12 and 24 months ]

Estimated Enrollment: 180
Study Start Date: October 2011
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin K2 supplementation Dietary Supplement: Menaquinone-7 (Vitamin K2)
Menaquinone-7 (Vitamin K2)
Placebo Comparator: Placebo control Other: Placebo capsules
Capsules containing no Menaquinone-7

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality
  • Baseline Agatston calciumscore 100 - 400

Exclusion Criteria:

  • Baseline-scan of insufficient quality
  • Heart rate greater than 70 beats per minute during first scan.(despite adequate treatment with metoprolol)
  • Chronic or paroxysmal Atrial Fibrillation
  • Presence or scheduled coronary revascularization procedure
  • History of myocardial infarction or stroke.
  • Presence of Diabetes Mellitus.
  • Known kidney disease or a Glomerular Filtration Rate (GFR)MDRD < 60 ml/min/1.73m2
  • Malignant disease (exception: treated basal-cell or squamous cell carcinoma).
  • Use of Vitamin K antagonists.
  • A life-expectancy < 2 years
  • Pregnancy or wish to become pregnant in the near future.
  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): NCT01002157


Contacts
Contact: Abraham Kroon, MD, PhD +31433877005 aa.kroon@MUMC.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6202 AZ
Principal Investigator: Abraham Kroon, MD, PhD         
Sub-Investigator: Barry van Varik, MD         
Sponsors and Collaborators
Maastricht University Medical Center
VitaK
Investigators
Principal Investigator: Abraham Kroon, MD, PhD Maastricht University Medical Center
Study Chair: Peter de Leeuw, MD, PhD Maastricht University Medical Center
  More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01002157     History of Changes
Other Study ID Numbers: MEC09-2-075
NL27372.068.09
First Submitted: October 26, 2009
First Posted: October 27, 2009
Last Update Posted: March 22, 2017
Last Verified: March 2016

Keywords provided by Maastricht University Medical Center:
Coronary Artery Calcification
Vitamin K
Trial
Treatment

Additional relevant MeSH terms:
Vitamin K
Vitamin K 2
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Calcinosis
Arteriosclerosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin MK 7
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants