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

Not Applicable

• Conditions: Metabolic Bone Disorder
• Interventions: Dietary Supplement: K2 vitamin; Dietary Supplement: Placebo

• Registration Number: NCT01922804
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-14
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28
• Primary Completion: 2017-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• postmenopausal women
• 60-80 years
• osteopenia

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K2 vitamin	K2 vitamin	K2 vitamin 375 microgram a day for 3 years
placebo	Placebo	1 tablet a day for 3 years

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 arterial stiffness, pulse wave velocity	Measured at baseline and after 6 months	Change in pulse wave velocity after 6 months.
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

Trial Locations

Locations (1)

Department of Endocrinology and Internal Medicine THG; 🇩🇰 Aarhus, Denmark