Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification (K2vita)

October 27, 2016 updated by: University of Aarhus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Endocrinology and Internal Medicine THG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: K2 vitamin
K2 vitamin 375 microgram a day for 3 years
Dietary supplement: K2 vitamin
K2 vitamin tablet
Placebo Comparator: placebo
1 tablet a day for 3 years
Dietary supplement: Placebo
Placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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
Time Frame: Assessed after 3, 6, 12, 24 and 36 months
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
Time Frame: Measured at baseline and after 6 months
Change in pulse wave velocity after 6 months.
Measured at baseline and after 6 months
Change in insulin sensitivity
Time Frame: 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.
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
Measured at baseline, after 1, 3, 6, 12, 24 and 36 months
Change in bone structure
Time Frame: baseline and month 12
HRpQCT scans
baseline and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Axellus

Investigators

  • Principal Investigator: Sofie Rønn, cand.med, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2vita

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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