NCT01002157

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
1.9 years until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

8 years

First QC Date

October 26, 2009

Last Update Submit

September 12, 2018

Conditions

Coronary Artery Disease

Keywords

Coronary Artery CalcificationVitamin KTrialTreatment

Outcome Measures

Primary Outcomes (1)

  • Coronary Artery Calcification-score progression

    12 and 24 months

Secondary Outcomes (2)

  • Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity

    0, 12 and 24 months

  • Carotid Intima Media Thickness

    0, 12 and 24 months

Study Arms (2)

Vitamin K2 supplementation

EXPERIMENTAL
Dietary Supplement: Menaquinone-7 (Vitamin K2)

Placebo control

PLACEBO COMPARATOR
Other: Placebo capsules

Interventions

Menaquinone-7 (Vitamin K2)DIETARY_SUPPLEMENT

Menaquinone-7 (Vitamin K2)

Vitamin K2 supplementation
Placebo capsulesOTHER

Capsules containing no Menaquinone-7

Placebo control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality
  • Baseline Agatston calciumscore 100 - 400

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

menaquinone 7Vitamin K 2

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Officials

  • Abraham Kroon, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Peter de Leeuw, MD, PhD

    Maastricht University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

October 1, 2011

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

NL(1)