Beneficial Effects of Long Term Menaquinone-7

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

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-09-30

Brief Summary

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From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and matrix-Gla protein (in the arterial vessel wall). The question remains whether supplementation with MK-7 also leads to measurable improvements of bone and vascular health. The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of an MK-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.

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Detailed Description

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Conditions

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Bone Loss Arteriosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-7

1 capsule per day existing of 180 µg menaquinone-7

Group Type ACTIVE_COMPARATOR

menaquinone-7

Intervention Type DIETARY_SUPPLEMENT

180 µg menaquinone-7 daily for three years

Placebo

1 placebo capsule per day for three years

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

1 placebo capsule daily for three years

Interventions

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menaquinone-7

180 µg menaquinone-7 daily for three years

Intervention Type DIETARY_SUPPLEMENT

placebo

1 placebo capsule daily for three years

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy postmenopausal women between 55 and 65 years old
* Subjects of normal body weight and height according to BMI \< 30
* Subjects of Caucasian race
* Subject has given written consent to take part in the study

Exclusion Criteria

* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects presenting chronic degenerative and/or inflammatory disease
* Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
* Subjects receiving corticoϊd treatment
* Subjects using oral anticoagulants
* Subject using bisphosphonates
* Subjects using hormone replacement therapy
* Subjects undergoing ovariectomy and/or hysterectomy
* Subject with (a history of) soy allergy
* Subjects using vitamin K containing multivitamins or vitamin K supplements
* Subjects who have participated in a clinical study more recently than one month before the current study
* Subjects who are found to be osteoporotic at baseline (T-score \< -2.5)

Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes