Beneficial Effects of Long Term Menaquinone-7

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Arteriosclerosis; Bone Loss

Treatments: Dietary Supplement: placebo; Dietary Supplement: menaquinone-7

Study type: Interventional

Funder types: Other

Identifiers

NCT00642551

07-3-074

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: Female

Ages: 55 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

MK-7

Active Comparator group

Description:

1 capsule per day existing of 180 µg menaquinone-7

Treatment:

Dietary Supplement: menaquinone-7

Placebo

Placebo Comparator group

Description:

1 placebo capsule per day for three years

Treatment:

Dietary Supplement: placebo