Intervention study on the effect of vitamin K2 (Menaquinone-7) supplementation on the vascular stiffness in subjects with poor vitamin K-status.

Recruiting

Conditions: vascular stiffness
vitamin K deficiency
10003216

Registration Number: NL-OMON47354

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 243

Inclusion Criteria

Men and women between 40 and 70 years of age
Subjects having a BMI between 20 and 35 kg/m2
Subjects of the Caucasian race
Subjects having circulating values of dp-ucMGP higher than 400 pmol/L
Subjects given written consent to take part in the study

Exclusion Criteria

Subjects with hyperlipedaemia
Subjects with cardiovascular disease
Women treated with estrogens
Subjects on oral anticoagulant therapy
Subjects with (a history of) metabolic or gastrointestinal disease
Subjects taking vitamin K containing (multi)vitamin supplements

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters of this study is to investigate the effects of<br /><br>MK-7 supplementation on vascular characteristics. The main study parameters are<br /><br>the percentage of changes in the clinical end points: pulse-wave velocity,<br /><br>carotid elasticity and intima-media thickness after one year of treatment<br /><br>between the two treatment groups (placebo and MK-7).<br /><br><br /><br>Primary study parameter of the follow-up study is to investigate the<br /><br>correlation between the 3 different non-invasive measurements for vascular<br /><br>stiffness among healthy subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameter is the relative changes in the biochemical<br /><br>parameters i.e. dp-ucMGP fraction after one year of treatment. </p><br>