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From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and matrix-Gla protein (in the arterial vessel wall). The question remains whether supplementation with MK-7 also leads to measurable improvements of bone and vascular health. The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of an MK-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-7 | Active Comparator | 1 capsule per day existing of 180 µg menaquinone-7 |
|
| Placebo | Placebo Comparator | 1 placebo capsule per day for three years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| menaquinone-7 | Dietary Supplement | 180 µg menaquinone-7 daily for three years |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound | three years |
| Measure | Description | Time Frame |
|---|---|---|
| The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP) | three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cees Vermeer, PhD | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VitaK BV / Maastricht University | Maastricht | PO Box 616 | 6200 MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22136751 | Derived | Knapen MH, Schurgers LJ, Shearer MJ, Newman P, Theuwissen E, Vermeer C. Association of vitamin K status with adiponectin and body composition in healthy subjects: uncarboxylated osteocalcin is not associated with fat mass and body weight. Br J Nutr. 2012 Sep 28;108(6):1017-24. doi: 10.1017/S000711451100626X. Epub 2011 Dec 5. |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001161 | Arteriosclerosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C062629 | menaquinone 7 |
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| placebo |
| Dietary Supplement |
1 placebo capsule daily for three years |
|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |