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| Name | Class |
|---|---|
| Axellus | INDUSTRY |
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The aims of the present study are to investigate the effect of vitamin K2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis.
Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.
Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.
Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.
Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K2 vitamin | Experimental | K2 vitamin 375 microgram a day for 3 years |
|
| placebo | Placebo Comparator | 1 tablet a day for 3 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K2 vitamin | Dietary Supplement | K2 vitamin tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| p-undercarboxylated osteocalcin | Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone mineral density | Change in bone mineral density measured by DXA scans (Dual energy x-ray absorptiometry) | Assessed after 3, 6, 12, 24 and 36 months |
| Change in arterial stiffness, pulse wave velocity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sofie Rønn, cand.med | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Internal Medicine THG | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33030563 | Derived | Ronn SH, Harslof T, Oei L, Pedersen SB, Langdahl BL. The effect of vitamin MK-7 on bone mineral density and microarchitecture in postmenopausal women with osteopenia, a 3-year randomized, placebo-controlled clinical trial. Osteoporos Int. 2021 Jan;32(1):185-191. doi: 10.1007/s00198-020-05638-z. Epub 2020 Oct 8. |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D024482 | Vitamin K 2 |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Dietary Supplement |
Placebo tablets |
|
Change in pulse wave velocity after 6 months.
| Measured at baseline and after 6 months |
| Change in insulin sensitivity | Change in insulin sensitivity. Determined by HOMA-test (homeostasis model assessment), using fasting plasma glucose and insulin. | Measured at baseline and after 1 and 12 months. |
| Change in bone turnover markers | Measured at baseline, after 1, 3, 6, 12, 24 and 36 months |
| Change in bone structure | HRpQCT scans | baseline and month 12 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |