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

N/AUnknownNCT01922804

University of Aarhus150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Metabolic Bone Disorder

Interventions

K2 vitaminDIETARY_SUPPLEMENT

K2 vitamin tablet

PlaceboDIETARY_SUPPLEMENT

Placebo tablets

Eligibility

Sex: FEMALEMin age: 60 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Department of Endocrinology and Internal Medicine THG

Aarhus, Denmark

Outcomes

Primary Outcomes

p-undercarboxylated osteocalcin

Time frame: Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial.

Secondary Outcomes

Change in bone mineral density

Change in bone mineral density measured by DXA scans (Dual energy x-ray absorptiometry)

Time frame: Assessed after 3, 6, 12, 24 and 36 months

Change in arterial stiffness, pulse wave velocity

Change in pulse wave velocity after 6 months.

Time frame: 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.

Time frame: Measured at baseline and after 1 and 12 months.

Change in bone turnover markers

Time frame: Measured at baseline, after 1, 3, 6, 12, 24 and 36 months

Change in bone structure

HRpQCT scans

Time frame: baseline and month 12

Data from ClinicalTrials.gov

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