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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01922804
First Posted: August 14, 2013
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Axellus
Information provided by (Responsible Party):
University of Aarhus
  Purpose

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.


Condition Intervention
Metabolic Bone Disorder Dietary Supplement: K2 vitamin Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)

  • Change in arterial stiffness, pulse wave velocity [ Time Frame: Measured at baseline and after 6 months ]
    Change in pulse wave velocity 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.

  • Change in bone turnover markers [ Time Frame: Measured at baseline, after 1, 3, 6, 12, 24 and 36 months ]
  • Change in bone structure [ Time Frame: baseline and month 12 ]
    HRpQCT scans


Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922804


Locations
Denmark
Department of Endocrinology and Internal Medicine THG
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Axellus
Investigators
Principal Investigator: Sofie Rønn, cand.med Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01922804     History of Changes
Other Study ID Numbers: K2vita
First Submitted: August 6, 2013
First Posted: August 14, 2013
Last Update Posted: October 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Calcinosis
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Metabolic Diseases
Musculoskeletal Diseases
Vitamins
Vitamin A
Micronutrients
Growth Substances
Physiological Effects of Drugs