The InterVitaminK Trial - Effects of Vitamin K Supplementation on Cardiovascular, Metabolic, and Bone Health
InterVitaminK
Novel Health Effects of Vitamin K: a Placebo-controlled Randomized Trial in the General Population (InterVitaminK)
1 other identifier
interventional
450
1 country
1
Brief Summary
The purpose of this study is to examine the effect of menaquinone-7 (MK-7) supplementation on cardiovascular, metabolic, and bone health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedStudy Start
First participant enrolled
June 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
February 17, 2026
February 1, 2026
4.6 years
January 7, 2022
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total coronary artery calcification
Total coronary artery calcification score (unit: Agatston score) in the coronary arteries, assessed by non-contrast Cardiac CT scans. A high score reflects higher degree of calcification in the coronary arteries and increased risk of coronary artery disease. The outcome will be evaluated by randomization group (active versus placebo).
Baseline to three years of follow-up
Secondary Outcomes (7)
Coronary plaque composition
Baseline to three years of follow-up
Arterial stiffness
Baseline to three years of follow-up
Blood pressure
Baseline to three years of follow-up
Aortic valve calcifications
Baseline to three years of follow-up
Bone mineral density
Baseline to three years of follow-up
- +2 more secondary outcomes
Other Outcomes (9)
Biomarkers of bone resorption
Baseline to three years of follow-up
Biomarkers of bone formation
Baseline to three years of follow-up
Lung function
Baseline to three years of follow-up
- +6 more other outcomes
Study Arms (2)
Intervention
EXPERIMENTALIntervention treatment . Dietary supplementation with Menaquinone-7 (MK-7) tablet (333 µg/day). MK-7 (K2VITAL®DELTA) tablets are manufactured by Kappa Bioscience AS, Oslo, Norway.
Placebo
PLACEBO COMPARATORPlacebo tablet (no active treatment). The placebo tablets will match the intervention treatment in both taste and appearance. Placebo tablets are manufactured by Kappa Bioscience AS, Oslo, Norway.
Interventions
One MK-7 tablet containing 333 µg MK-7 per day
Eligibility Criteria
You may qualify if:
- Detectable CAC (Agatson score \>=10) assessed by Cardiac Computed Tomography (CT) scan in the Inter99 20-year follow-up study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Clinical Research and Prevention
Copenhagen, Glostrup, DK-2600, Denmark
Related Publications (1)
Kampmann FB, Thysen SM, Nielsen CFB, Kofoed KF, Kober L, Pham MHC, Vaag A, Jorgensen NR, Petersen J, Jacobsen RK, Karhus LL, Diederichsen A, Frimodt-Moller M, Linneberg A. Study protocol of the InterVitaminK trial: a Danish population-based randomised double-blinded placebo-controlled trial of the effects of vitamin K (menaquinone-7) supplementation on cardiovascular, metabolic and bone health. BMJ Open. 2023 May 19;13(5):e071885. doi: 10.1136/bmjopen-2023-071885.
PMID: 37208133DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, data collectors, and investigators are blinded of the allocation throughout the study period. The randomization list is generated and kept by a statistician employed at the Center for Clinical Research and Prevention, but not involved in the trial. Kappa Bioscience AS, Oslo, Norway, keeps the randomization list for labelling of investigational products. The randomization list will be made available to one DSMB member if safety concerns arise during the study period.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Professor, MD, PhD
Study Record Dates
First Submitted
January 7, 2022
First Posted
February 28, 2022
Study Start
June 21, 2022
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
After the publication of the main results upon completion of the trial, data will be available on a collaborative basis following approval from the InterVitaminK Trial Steering Committee and the regional data protection authority.