Metabolic Bone Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTK2 vitamin
K2 vitamin tablet
DIETARY_SUPPLEMENTPlacebo
Placebo tablets
Sponsors
Axellus
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* postmenopausal women * 60-80 years * osteopenia
Exclusion criteria
* Calcium metabolic, thyroid, liver or kidney disease * Diabetes * Obesity * Myocardial infarction or other arteriosclerotic events * Angina pectoris * Vitamin D \< 50 nmol/L * Treatment with vitamin K antagonists * Use of vitamin K supplements in the last month or for more than 3 months at any time * Treatment with drugs with known effects on bone metabolism or glucose metabolism. * Smoking in the last 12 months * Drug or alcohol abuse * Allergy to calcium, vitamin D or vitamin K.
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in bone mineral density | Assessed after 3, 6, 12, 24 and 36 months | Change in bone mineral density measured by DXA scans (Dual energy x-ray absorptiometry) |
| Change in arterial stiffness, pulse wave velocity | Measured at baseline and after 6 months | Change in pulse wave velocity after 6 months. |
| Change in insulin sensitivity | Measured at baseline and after 1 and 12 months. | Change in insulin sensitivity. Determined by HOMA-test (homeostasis model assessment), using fasting plasma glucose and insulin. |
| Change in bone turnover markers | Measured at baseline, after 1, 3, 6, 12, 24 and 36 months | — |
| Change in bone structure | baseline and month 12 | HRpQCT scans |
Countries
Denmark
Outcome results
None listed