Vitamin K2 for Reduction the Calcium at Carotid Bifurcation in Patients With Subcritical Lesions

May 21, 2019 updated by: yamume tshomba, Scientific Institute San Raffaele

Role of Vitamin K2 in the Reduction of the Calcium Content at the Level of the Carotid Bifurcation in Patients With Subcritical Lesions

Clinical study single center, prospective, randomized, controlled (vs. no supplement), open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12 months will not know the treatment given to the patient, because the diagnostic test in question is considered operator-dependent), a "parallel group", which aims is evaluate the reduction in the level of calcium in the carotid artery and the carotid atherosclerotic plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid bifurcation with a range of 40-60%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20132
        • San Raffaele Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Ability to provide written informed consent
  3. subjects with calcified lesions subcritical from the carotid bifurcation. with a range of 40-60% calculated method with ECTS (European Carotid Surgery Trial)

Exclusion Criteria:

  1. Patients with reduced life expectancy or age> 80 years,
  2. Patients already subjected to other clinical trial in the previous three months,
  3. Patients with hypersensitivity or with known allergies to acetylsalicylic acid, patients with pre-existing mastocytosis, a history of asthma induced by salicylates, duodenal ulcer, bleeding diathesis, severe hepatic insufficiency, severe heart failure, concomitant treatment with methotrexate, last trimester of pregnancy.
  4. Patients with known hypersensitivity to vitamin K2 and vitamin D, people with hemolytic diseases, concomitant anticoagulant therapy, people with cancer, MAV (arteriovenous malformations) and / or cerebral aneurysms, hypercalcemia, nephrolithiasis and renal failure.
  5. Uncooperative patients , or allergies related to the substance under study or with any contra-indicated in the data sheet / Summary of Product Characteristics (SPC) of the substances in the studio.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group with K2

The nutraceutical product (PLAK2) based on vitamin K2, will be administered once a day (a tablet 800mg) for 12 months.

All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)
Other: Nutraceutical product based on vitamin K2 (PLAK2)
Other Names:
  • PLAK2
No Intervention: Control group (no vitamin K2)
The control group did not take the supplement of Vitamin K2. All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scientific Institute San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAK2/74/OSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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