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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: September 2011

Intervention(s) in this Clinical Trial

• Dietary Supplement: menaquinone-7
  • 180 µg menaquinone-7 daily for three years
• Dietary Supplement: placebo
  • 1 placebo capsule daily for three years

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: MK-7
  • 1 capsule per day existing of 180 µg menaquinone-7
• Placebo Comparator: Placebo
  • 1 placebo capsule per day for three years

Primary Measures

• Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound
  • Time Frame: three years
    Safety Issue?: No

Secondary Measures

• The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)
  • Time Frame: three years
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Maastricht University

Overall Clinical Trial Officials and Contacts

Cees Vermeer, PhD Principal Investigator Maastricht University  

Overall Contact: Cees Vermeer, PhD +31433881682 c.vermeer@bioch.unimaas.nl

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642551

Study ID Number: 07-3-074

ClinicalTrials.gov Identifier: NCT00642551

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)