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| ID | Type | Description | Link |
|---|---|---|---|
| NL27372.068.09 |
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| Name | Class |
|---|---|
| VitaK | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin K2 supplementation | Experimental |
| |
| Placebo control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menaquinone-7 (Vitamin K2) | Dietary Supplement | Menaquinone-7 (Vitamin K2) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary Artery Calcification-score progression | 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity | 0, 12 and 24 months | |
| Carotid Intima Media Thickness | 0, 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abraham Kroon, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Peter de Leeuw, MD, PhD | Maastricht University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | 6202 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42268593 | Derived | Vossen LM, de Leeuw PW, Schurgers LJ, Heuts S, Adriaans BP, de Haan C, van Varik BJ, Kroon AA. Two Years of Menaquinone-7 Supplementation and Coronary Artery Calcification: A Randomized Clinical Trial. JAMA Cardiol. 2026 Jun 10:e261279. doi: 10.1001/jamacardio.2026.1279. Online ahead of print. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C062629 | menaquinone 7 |
| D024482 | Vitamin K 2 |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Placebo capsules |
| Other |
Capsules containing no Menaquinone-7 |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |