Vascular Stiffness Clinical Trial
Official title:
Intervention Study on the Effect of Vitamin K2 (Menaquinone-7) Supplementation on the Vascular Stiffness in Subjects With Poor Vitamin K-status
Verified date | April 2018 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Vitamin K is required for the activation of the inhibitor of vascular calcification: Matrix
Gla Protein (MGP). In an earlier study the beneficial effect of menaquinone-7 (MK-7), a
vitamin K2 form, was observed on the stiffness of the vessel wall in postmenopausal women. It
decreased the circulating form of inactive MGP and improved the vascular elasticity (local)
and aortic pulse wave velocity (regional). The decrease of circulating inactive MGP was
observed after 2-3 months MK-7 supplementation and the effect of MK-7 on the clinical
endpoints was observed within 3 years of supplementation. It is demonstrated in several
studies that cardiovascular risk increases with decreasing vitamin K intake and increasing
levels of inactive MGP. In this study the investigators select subjects in the highest
tertile of circulating inactive MGP. This study group will consist of subjects with increased
cardiovascular risk and it is expected that effects of MK-7 on clinical endpoints in this
group will be measurable within 1 year of supplementation.
Vascular stiffness can be determined with different techniques. The vascular characteristics
determined with Pulse Wave Velocity (PWV), ultrasound of the common carotid artery and
accelerated plethysmography (APG) with a fingertip device will be compared in a follow-up
study.
Status | Active, not recruiting |
Enrollment | 240 |
Est. completion date | September 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Men and women between 40 and 70 years old - Subjects with body weight and height according to BMI between 20 and 35 kg/m2 - Subjects of Caucasian race - Subject has given written consent to take part in the study - Subjects with circulating dp-ucMGP higher than 400 pmol/L Exclusion Criteria: - Subjects with cardiovascular disease - Subjects with hyperlipidaemia - Subjects with (a history of) metabolic or gastrointestinal disease - Subjects presenting chronic degenerative and/or inflammatory disease - Use of more than 3 units alcohol/day - Subjects receiving oestrogen treatment (women) - Subjects using corticosteroids - Subjects using oral anticoagulants and subjects with clotting disorders - Subjects using vitamin K containing multivitamins or supplements |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Follow-up study outcome: Accelerated phlethysmography (APG) | Accelerated plethysmography measurements will be assessed using an fingertip oximeter indicating Stiffness Score 1 through 6. | Up to 1 year post-intervention | |
Primary | Change from baseline carotid-femoral Pulse Wave Velocity (PWV) at 1 year | PWV (in m/s) will be assessed noninvasively by measuring carotid-femoral PWV, using mechanotransducers applied directly on the skin. | 1 year | |
Secondary | Change from baseline diameter of the common carotid artery at 1 year | The diameter of the common carotid artery will be measured using a linear array transducer connected to an ultrasound scanner. The diameter will be assessed in mm. | 1 year | |
Secondary | Diameter of the common carotid artery | The diameter of the common carotid artery will be measured using a linear array transducer connected to an ultrasound scanner. The diameter will be assessed in mm. | up to 1 year post-intervention | |
Secondary | Change from baseline distension of the common carotid artery at 1 year | The distension of the common carotid artery will be measured using a linear array transducer connected to an ultrasound scanner. The distension will be assessed in micrometer. | 1 year | |
Secondary | Distension of the common carotid artery | The distension of the common carotid artery will be measured using a linear array transducer connected to an ultrasound scanner. The distension will be assessed in micrometer. | up to 1 year post-intervention | |
Secondary | Change from baseline intima-media thickness (IMT) of the common carotid artery at 1 year | The IMT of the common carotid artery will be measured using a linear array transducer connected to an ultrasound scanner. The IMT will be assessed in micrometer. | 1 year | |
Secondary | Intima-media thickness (IMT) of the common carotid artery | The IMT of the common carotid artery will be measured using a linear array transducer connected to an ultrasound scanner. The IMT will be assessed in micrometer. | up to 1 year post-intervention | |
Secondary | circulating inactive Matrix Gla Protein (dp-ucMGP) | Dp-ucMGP (in pM) will be measured using a sandwich ELISA, based on monoclonal antibodies. | baseline and 1 year | |
Secondary | carotid-femoral Pulse Wave Velocity (PWV) | PWV (in m/s) will be assessed noninvasively by measuring carotid-femoral PWV, using mechanotransducers applied directly on the skin. | up to 1 year post-intervention |
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