Beneficial Effects of Long Term Menaquinone-7

Not Applicable

Completed

• Conditions: Bone Loss; Arteriosclerosis
• Interventions: Dietary Supplement: menaquinone-7; Dietary Supplement: placebo

• Registration Number: NCT00642551
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-25
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-7	menaquinone-7	1 capsule per day existing of 180 µg menaquinone-7
Placebo	placebo	1 placebo capsule per day for three years

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)	three years

Trial Locations

Locations (1)

VitaK BV / Maastricht University; 🇳🇱 Maastricht, PO Box 616, Netherlands