Coronary Artery DiseaseVitaK-CACNCT01002157
The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification
A study testing Menaquinone-7 (Vitamin K2) in people with Coronary Artery Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Menaquinone-7 (Vitamin K2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality
- Baseline Agatston calciumscore 100 - 400
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, 6202 AZ
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Menaquinone-7 (Vitamin K2), Placebo capsules
- Keywords
- Coronary Artery Calcification, Vitamin K, Trial, Treatment
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menaquinone-7 (Vitamin K2)Dietary supplement
Menaquinone-7 (Vitamin K2)
Placebo capsulesOther
Capsules containing no Menaquinone-7
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K2 supplementation | Experimental | Not described Receives: Dietary Supplement: Menaquinone-7 (Vitamin K2) |
| Placebo control | Placebo comparator | Not described Receives: Other: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Artery Calcification-score progression
Measured: 12 and 24 months
Secondary outcomes (2)
Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity
Measured: 0, 12 and 24 months
Carotid Intima Media Thickness
Measured: 0, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startOct 2011
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VitaK
- Responsible party
- Sponsor
- Investigators
- Abraham Kroon, MD, PhD, Principal investigator, Maastricht University Medical CenterPeter de Leeuw, MD, PhD, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002157
- Sponsor's protocol ID
- MEC09-2-075
- Other IDs
- NL27372.068.09
- Acronym
- VitaK-CAC
- Status last verified
- Sep 2018
- First submitted
- 26 Oct 2009
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vossen LM, de Leeuw PW, Schurgers LJ, Heuts S, Adriaans BP, de Haan C, van Varik BJ, Kroon AA. Two Years of Menaquinone-7 Supplementation and Coronary Artery Calcification: A Randomized Clinical Trial. JAMA Cardiol. 2026 Aug 1;11(8):719-726. doi: 10.1001/jamacardio.2026.1279.
PubMed 42268593
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification
- ClinicalTrials.gov ID
- NCT01002157
- Acronym / sponsor ID
- VitaK-CAC / MEC09-2-075
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Calcification, Vitamin K, Trial, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- VitaK
- Study start
- Oct 2011
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin K2 supplementation | Experimental | Dietary Supplement: Menaquinone-7 (Vitamin K2) |
| Placebo control | Placebo comparator | Other: Placebo capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality
- Baseline Agatston calciumscore 100 - 400
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menaquinone-7 (Vitamin K2)Menaquinone-7 (Vitamin K2) | Dietary supplement | Vitamin K2 supplementation |
| Placebo capsulesCapsules containing no Menaquinone-7 | Other | Placebo control |
Primary outcome
Coronary Artery Calcification-score progression
Time frame: 12 and 24 months
2 secondary outcomes
Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity
Time frame: 0, 12 and 24 months
Carotid Intima Media Thickness
Time frame: 0, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Derived from this study: PubMed 42268593Vossen LM, de Leeuw PW, Schurgers LJ, Heuts S, Adriaans BP, de Haan C, van Varik BJ, Kroon AA. Two Years of Menaquinone-7 Supplementation and Coronary Artery Calcification: A Randomized Clinical Trial. JAMA Cardiol. 2026 Aug 1;11(8):719-726. doi: 10.1001/jamacardio.2026.1279.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Kroon, MD, PhD principal investigator
Maastricht University Medical Center
Peter de Leeuw, MD, PhD study chair
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menaquinone-7 (Vitamin K2) in people with Coronary Artery Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Artery Calcification-score progression (time frame: 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.