NCT02404519

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

March 23, 2015

Last Update Submit

April 26, 2018

Conditions

Vascular Stiffness

Keywords

Vitamin KMenaquinone-7Matrix Gla ProteinVascular stiffness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change from baseline diameter of the common carotid artery at 1 year

    1 year

  • Diameter of the common carotid artery

    up to 1 year post-intervention

  • Change from baseline distension of the common carotid artery at 1 year

    1 year

  • Distension of the common carotid artery

    up to 1 year post-intervention

  • Change from baseline intima-media thickness (IMT) of the common carotid artery at 1 year

    1 year

  • +3 more secondary outcomes

Other Outcomes (1)

  • Follow-up study outcome: Accelerated phlethysmography (APG)

    Up to 1 year post-intervention

Study Arms (2)

Menaquinone-7

ACTIVE COMPARATOR

Menaquinone-7 180 microgram tablet, by mouth, daily for 1 year

Dietary Supplement: Menaquinone-7

Placebo

PLACEBO COMPARATOR

Placebo tablet, by mouth, daily for 1 year

Dietary Supplement: Placebo

Interventions

Menaquinone-7DIETARY_SUPPLEMENT

1 tablet containing 180 micrograms MK-7 taken orally every day during 1 year

Also known as: MK-7
Menaquinone-7
PlaceboDIETARY_SUPPLEMENT

1 tablet without MK-7 taken orally every day during 1 year

Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

menaquinone 7

Study Officials

  • Marjo HJ Knapen, BSc

    VitaK BV/Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marjo Knapen, BSc

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 31, 2015

Study Start

January 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

April 30, 2018

Record last verified: 2018-04