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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Aarhus
Sponsor:
Collaborator:
axellus
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01922804
First received: August 6, 2013
Last updated: August 13, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in bone mineral density [ Time Frame: Assessed after 3, 6 and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in pulse wave velocity after 6 months.

  • Change in insulin sensitivity [ Time Frame: Measured at baseline and after 1 months ] [ Designated as safety issue: No ]
    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 and 12 months ] [ Designated as safety issue: No ]
  • Change in bone structure [ Time Frame: baseline and month 12 ] [ Designated as safety issue: No ]
    HRpQCT scans


Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: K2 vitamin
K2 vitamin 375 microgram a day for 1 year
Dietary Supplement: K2 vitamin
K2 vitamin tablet
Placebo Comparator: placebo
1 tablet a day for 1 year
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

Ages Eligible for Study:   60 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922804

Contacts
Contact: Sofie Roenn, cand.med. nanroe@rm.dk

Locations
Denmark
Department of Endocrinology and Internal Medicine THG Recruiting
Aarhus, Denmark, 8000
Contact: Sofie Roenn, cand.med.       nanroe@rm.dk   
Principal Investigator: Sofie Roenn, cand.med.         
Sponsors and Collaborators
University of Aarhus
axellus
Investigators
Principal Investigator: Sofie Rønn, cand.med Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01922804     History of Changes
Other Study ID Numbers: K2vita
Study First Received: August 6, 2013
Last Updated: August 13, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Calcinosis
Vascular Calcification
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014