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

September 12, 2018 updated by: Maastricht University Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control
Other: Placebo capsules
Capsules containing no Menaquinone-7
Experimental: Vitamin K2 supplementation
Dietary supplement: Menaquinone-7 (Vitamin K2)
Menaquinone-7 (Vitamin K2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coronary Artery Calcification-score progression
Time Frame: 12 and 24 months
12 and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity
Time Frame: 0, 12 and 24 months
0, 12 and 24 months
Carotid Intima Media Thickness
Time Frame: 0, 12 and 24 months
0, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

VitaK

Investigators

  • Principal Investigator: Abraham Kroon, MD, PhD, Maastricht University Medical Center
  • Study Chair: Peter de Leeuw, MD, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC09-2-075
  • NL27372.068.09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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