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

Primary Purpose

Metabolic Bone Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

K2 vitamin

Placebo

About this trial

This is an interventional prevention trial for Metabolic Bone Disorder

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Department of Endocrinology and Internal Medicine THG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

K2 vitamin

placebo

Arm Description

K2 vitamin 375 microgram a day for 3 years

1 tablet a day for 3 years

Outcomes

Primary Outcome Measures

p-undercarboxylated osteocalcin

Secondary Outcome Measures

Change in bone mineral density

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

Change in arterial stiffness, pulse wave velocity

Change in pulse wave velocity after 6 months.

Change in insulin sensitivity

Change in insulin sensitivity. Determined by HOMA-test (homeostasis model assessment), using fasting plasma glucose and insulin.

Change in bone turnover markers

Change in bone structure

HRpQCT scans

Full Information

NCT ID

NCT01922804

First Posted

August 6, 2013

Last Updated

October 27, 2016

Sponsor

University of Aarhus

Collaborators

Axellus

1. Study Identification

Unique Protocol Identification Number

NCT01922804

Brief Title

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

Acronym

K2vita

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

April 2017 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Axellus

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Bone Disorder

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

K2 vitamin

Arm Type

Experimental

Arm Description

K2 vitamin 375 microgram a day for 3 years

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

1 tablet a day for 3 years

Intervention Type

Dietary Supplement

Intervention Name(s)

K2 vitamin

Intervention Description

K2 vitamin tablet

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Change in bone mineral density

Description

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

Title

Change in arterial stiffness, pulse wave velocity

Description

Change in pulse wave velocity after 6 months.

Time Frame

Measured at baseline and after 6 months

Title

Change in insulin sensitivity

Description

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.

Title

Change in bone turnover markers

Time Frame

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

Title

Change in bone structure

Description

HRpQCT scans

Time Frame

baseline and month 12

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sofie Rønn, cand.med

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Endocrinology and Internal Medicine THG

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

33030563

Citation

Ronn SH, Harslof T, Oei L, Pedersen SB, Langdahl BL. The effect of vitamin MK-7 on bone mineral density and microarchitecture in postmenopausal women with osteopenia, a 3-year randomized, placebo-controlled clinical trial. Osteoporos Int. 2021 Jan;32(1):185-191. doi: 10.1007/s00198-020-05638-z. Epub 2020 Oct 8.

Results Reference

derived

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

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