Metabolic Bone Disorder Clinical Trial
— K2vitaOfficial title:
Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification
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.
| Status | Active, not recruiting |
| Enrollment | 150 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 60 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Endocrinology and Internal Medicine THG | Aarhus |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aarhus | Axellus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | p-undercarboxylated osteocalcin | Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial. | No | |
| Secondary | 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 | No |
| Secondary | Change in arterial stiffness, pulse wave velocity | Change in pulse wave velocity after 6 months. | Measured at baseline and after 6 months | No |
| Secondary | 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. | No |
| Secondary | Change in bone turnover markers | Measured at baseline, after 1, 3, 6, 12, 24 and 36 months | No | |
| Secondary | Change in bone structure | HRpQCT scans | baseline and month 12 | No |