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

Coronary Artery Disease Clinical Trial

— VitaK-CAC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01002157
• Other study ID #: MEC09-2-075
• Secondary ID: NL27372.068.09
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2011
• Est. completion date: October 2019

Study information

• Verified date: September 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Dietary Supplement:
• Menaquinone-7 (Vitamin K2)
Menaquinone-7 (Vitamin K2)

Other:
• Placebo capsules
Capsules containing no Menaquinone-7

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	VitaK

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Artery Calcification-score progression		12 and 24 months
Secondary	Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity		0, 12 and 24 months
Secondary	Carotid Intima Media Thickness		0, 12 and 24 months