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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Maastricht University Medical Center
Sponsor:
Collaborator:
VitaK
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01002157
First received: October 26, 2009
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Coronary Artery Disease
Dietary Supplement: Menaquinone-7 (Vitamin K2)
Other: Placebo capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Coronary Artery Calcification-score progression [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity [ Time Frame: 0, 12 and 24 months ] [ Designated as safety issue: No ]
  • Carotid Intima Media Thickness [ Time Frame: 0, 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2011
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002157

Contacts
Contact: Barry van Varik, MD +31433881004 b.vanvarik@intmed.unimaas.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6202 AZ
Principal Investigator: Abraham Kroon, MD, PhD         
Sub-Investigator: Barry van Varik, MD         
Sponsors and Collaborators
Maastricht University Medical Center
VitaK
Investigators
Principal Investigator: Abraham Kroon, MD, PhD Maastricht University Medical Center
Study Chair: Peter de Leeuw, MD, PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01002157     History of Changes
Other Study ID Numbers: MEC09-2-075, NL27372.068.09
Study First Received: October 26, 2009
Last Updated: October 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Coronary Artery Calcification
Vitamin K
Trial
Treatment

Additional relevant MeSH terms:
Arteriosclerosis
Calcinosis
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Calcium Metabolism Disorders
Cardiovascular Diseases
Heart Diseases
Metabolic Diseases
Vascular Diseases
Vitamin K
Vitamin K 2
Vitamin MK 7
Vitamins
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Growth Substances
Hematologic Agents
Hemostatics
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014