Effects of Vitamin K on Heart, Metabolism, and Bone Health
Novel Health Effects of Vitamin K: a Placebo-controlled Randomized Trial in the General Population (InterVitaminK)
This study is testing if taking a vitamin K supplement can help people with heart issues and improve their bone health over three years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 1 site (Copenhagen, Glostrup) |
| Trial ID | NCT05259046 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of menaquinone-7 (MK-7) supplementation on cardiovascular, metabolic, and bone health. It is a double-blinded, placebo-controlled, randomized intervention involving participants with detectable coronary artery calcification (CAC). Over three years, participants will receive either MK-7 or a placebo, with health examinations and CT scans conducted at baseline and after three years to assess changes in CAC. The study aims to determine if MK-7 can significantly reduce the progression of CAC compared to placebo.
Who should consider this trial
Good fit: Ideal candidates are individuals with detectable coronary artery calcification (Agatson score >=10) who are part of the Inter99 cohort.
Not a fit: Patients with manifest cardiovascular disease or those on vitamin K antagonists will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive strategy for reducing cardiovascular disease risk and improving bone health.
How similar studies have performed: While there is preliminary evidence suggesting vitamin K's benefits, this study represents a larger, more rigorous investigation into its effects, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Detectable CAC (Agatson score \>=10) assessed by Cardiac Computed Tomography (CT) scan in the Inter99 20-year follow-up study Exclusion Criteria: * 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
Where this trial is running
Copenhagen, Glostrup
- Center for Clinical Research and Prevention — Copenhagen, Glostrup, Denmark (Recruiting)
Study contacts
- Study coordinator: Allan Linneberg, MD
- Email: allan.linneberg@regionh.dk
- Phone: +45 38163118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.