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

NCT ID: NCT01922804

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Metabolic Bone Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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K2 vitamin

K2 vitamin 375 microgram a day for 3 years

Group Type EXPERIMENTAL

K2 vitamin

Intervention Type DIETARY_SUPPLEMENT

K2 vitamin tablet

placebo

1 tablet a day for 3 years

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo tablets

Interventions

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K2 vitamin

K2 vitamin tablet

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo tablets

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Axellus

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sofie Rønn, cand.med

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Department of Endocrinology and Internal Medicine THG

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33030563 (View on PubMed)

Other Identifiers

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K2vita

Identifier Type: -

Identifier Source: org_study_id