NCT01923012

Brief Summary

Randomized placebo-controlled study with vitamine K2 (Menaquinone-4) in calcified carotid stenosis. We evaluate the plaque remodelling after administration of vitamine, reducing the calcified component.

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
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

August 13, 2013

Last Update Submit

May 24, 2014

Conditions

Carotid DiseaseAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Percentage reduction in plaque calcification and carotid stenosis

    One year

Study Arms (1)

Vitamin K2

EXPERIMENTAL
Drug: Vitamin K2 (Menaquinone)

Interventions

Vitamin K2 (Menaquinone)DRUG
Vitamin K2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • carotid stenosis between 50 and 70% (NASCET criteria) with calcified plaque

You may not qualify if:

  • renal and/or hepatic failure
  • diseases with secondary calcifications
  • dementia
  • previous strokes
  • concomitant use of anticoagulants
  • concomitant infections
  • pregnancy or breastfeeding
  • reduced patient's compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atherosclerosis

Interventions

Vitamin K 2

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 13, 2013

First Posted

August 14, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2015

Last Updated

May 28, 2014

Record last verified: 2014-05