Beneficial Effects of Long Term Menaquinone-7

Study Overview
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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.

Official Title
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Clinical Trial on Beneficial Effects of Long Term Menaquinone-7 (Vitamin K2) Intake by Postmenopausal Women

Conditions
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Bone Loss, Arteriosclerosis

Intervention / Treatment
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* Dietary Supplement: menaquinone-7
* Dietary Supplement: placebo


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MK-7<br>1 capsule per day existing of 180 µg menaquinone-7 | Dietary Supplement: menaquinone-7<br>* 180 µg menaquinone-7 daily for three years<br>|
| Placebo Comparator: Placebo<br>1 placebo capsule per day for three years | Dietary Supplement: placebo<br>* 1 placebo capsule daily for three years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP) |  | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin K2, menaquinone-7, bone health, vascular health