The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification

Last updated: September 12, 2018
Sponsor: Maastricht University Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Atherosclerosis

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT01002157
MEC09-2-075
NL27372.068.09
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older

  • Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality

  • Baseline Agatston calciumscore 100 - 400

Exclusion

Exclusion Criteria:

  • Baseline-scan of insufficient quality

  • Heart rate greater than 70 beats per minute during first scan.(despite adequatetreatment 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 Design

Total Participants: 180
Study Start date:
October 01, 2011
Estimated Completion Date:
October 31, 2019

Connect with a study center

  • Maastricht University Medical Center

    Maastricht, 6202 AZ
    Netherlands

    Site Not Available

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