Clinical trial NCT01002157: The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification
Official title: The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Calcification
Vitamin K
Trial
Treatment
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: VitaK
First posted: 2009-10-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Coronary Artery Calcification-score progression
timeFrame: 12 and 24 months
Secondary outcomes:
measure: Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity
timeFrame: 0, 12 and 24 months
measure: Carotid Intima Media Thickness
timeFrame: 0, 12 and 24 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Abraham Kroon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Peter de Leeuw, MD, PhD
role: STUDY_CHAIR
References: