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

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Other: Placebo capsules; Dietary Supplement: Menaquinone-7 (Vitamin K2)

Study type: Interventional

Funder types: Other

Identifiers

NCT01002157

MEC09-2-075

NL27372.068.09

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

Vitamin K2 supplementation

Experimental group

Treatment:

Dietary Supplement: Menaquinone-7 (Vitamin K2)

Placebo control

Placebo Comparator group

Treatment:

Other: Placebo capsules