Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification

Study Overview
=================
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.

Official Title
-----------------
Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification

Conditions
-----------------
Metabolic Bone Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: K2 vitamin
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K2 vitamin<br>K2 vitamin 375 microgram a day for 3 years | Dietary Supplement: K2 vitamin<br>* K2 vitamin tablet<br>|
| Placebo Comparator: placebo<br>1 tablet a day for 3 years | Dietary Supplement: Placebo<br>* Placebo tablets<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |