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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2019-10-31

Brief Summary

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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.

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TERMINATED PHASE2

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin K2 supplementation

Group Type EXPERIMENTAL

Menaquinone-7 (Vitamin K2)

Intervention Type DIETARY_SUPPLEMENT

Menaquinone-7 (Vitamin K2)

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type OTHER

Capsules containing no Menaquinone-7

Interventions

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Menaquinone-7 (Vitamin K2)

Intervention Type DIETARY_SUPPLEMENT

Placebo capsules

Capsules containing no Menaquinone-7

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No