The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification (NCT01002157) | Clinical Trial Compass
UnknownNot Applicable
The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification
Netherlands180 participantsStarted 2011-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.