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

October 26, 2009
October 19, 2011
October 2011
September 2015   (final data collection date for primary outcome measure)
Coronary Artery Calcification-score progression [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01002157 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification
The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Dietary Supplement: Menaquinone-7 (Vitamin K2)
    Menaquinone-7 (Vitamin K2)
  • Other: Placebo capsules
    Capsules containing no Menaquinone-7
  • Experimental: Vitamin K2 supplementation
    Intervention: Dietary Supplement: Menaquinone-7 (Vitamin K2)
  • Placebo Comparator: Placebo control
    Intervention: Other: Placebo capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
Not Provided
September 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Barry van Varik, MD +31433881004 b.vanvarik@intmed.unimaas.nl
Netherlands
 
NCT01002157
MEC09-2-075, NL27372.068.09
Yes
Maastricht University Medical Center
Maastricht University Medical Center
VitaK
Principal Investigator: Abraham Kroon, MD, PhD Maastricht University Medical Center
Study Chair: Peter de Leeuw, MD, PhD Maastricht University Medical Center
Maastricht University Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP