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Trial record 1 of 1 for:    NCT01002157
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The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification (VitaK-CAC)

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ClinicalTrials.gov Identifier: NCT01002157
Recruitment Status : Unknown
Verified September 2018 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : October 27, 2009
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
VitaK
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Dietary Supplement: Menaquinone-7 (Vitamin K2) Other: Placebo capsules Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification
Study Start Date : October 2011
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Vitamin K
Drug Information available for: Menadione

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitamin K2 supplementation Dietary Supplement: Menaquinone-7 (Vitamin K2)
Menaquinone-7 (Vitamin K2)
Placebo Comparator: Placebo control Other: Placebo capsules
Capsules containing no Menaquinone-7


Outcome Measures
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Primary Outcome Measures :
  1. Coronary Artery Calcification-score progression [ Time Frame: 12 and 24 months ]

Secondary Outcome Measures :
  1. Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity [ Time Frame: 0, 12 and 24 months ]
  2. Carotid Intima Media Thickness [ Time Frame: 0, 12 and 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002157


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
VitaK
Investigators
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Principal Investigator: Abraham Kroon, MD, PhD Maastricht University Medical Center
Study Chair: Peter de Leeuw, MD, PhD Maastricht University Medical Center
More Information
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01002157    
Other Study ID Numbers: MEC09-2-075
NL27372.068.09
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Keywords provided by Maastricht University Medical Center:
Coronary Artery Calcification
Vitamin K
Trial
Treatment
Additional relevant MeSH terms:
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Coronary Artery Disease
Calcinosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium Metabolism Disorders
Metabolic Diseases
 Vitamin K
Vitamin K 2
Menaquinone 7
Vitamins
Micronutrients
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants