Status:
RECRUITING
The InterVitaminK Trial - Effects of Vitamin K Supplementation on Cardiovascular, Metabolic, and Bone Health
Lead Sponsor:
Bispebjerg Hospital
Conditions:
Coronary Artery Calcification
Arterial Stiffness
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effect of menaquinone-7 (MK-7) supplementation on cardiovascular, metabolic, and bone health.
Detailed Description
Background: Research suggest that vitamin K may have protective effects against non-communicable and age-related diseases as diverse as cardiovascular disease (CVD), osteoporosis, and type 2 diabetes ...
Eligibility Criteria
Inclusion
- Detectable CAC (Agatson score \>=10) assessed by Cardiac Computed Tomography (CT) scan in the Inter99 20-year follow-up study
Exclusion
- Manifest CVD (prior cerebral infarct, prior myocardial infarct, prior percutaneous coronary intervention or prior coronary artery bypass surgery)
- Noise on the CT scan, which complicates an accurate assessment of CAC and interpretation of the CT scan. An example is a pacemaker
- Current treatment with Vitamin K antagonist (VKA).
- History of coagulation disorders (hemophilia, von Willebrand disease, sickle cell anemia)
- Active malignant disease (ongoing treatment)
- Previous surgical removal of the thyroid gland, or one or more of the parathyroid glands
- Regular use of vitamin K supplements other than trial tablets
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05259046
Start Date
June 21 2022
End Date
December 1 2026
Last Update
April 14 2023
Active Locations (1)
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1
Center for Clinical Research and Prevention
Copenhagen, Glostrup, Denmark, DK-2600