Evaluation of Coagulation in Multiple Sclerosis

July 27, 2017 updated by: Bastyr University

A Cross-Sectional Study of Coagulation in Multiple Sclerosis

Recent research in multiple sclerosis (MS) have suggested that altered coagulation and vascular inflammation may play a role in pathophysiology of MS. Sonoclot is viscoelastic method of analyzing clot formation. This instrument will be used to compare coagulation in individuals with MS to healthy controls. A 24-hour dietary recall and food frequency questionnaire will help determine whether coagulation is modified by fish consumption.

Study Overview

Status

Completed

Conditions

Detailed Description

This case-control study will recruit individuals with a diagnosis of MS and healthy controls. Individuals will be asked to come to Bastyr Clinical Research Center for a single study visit, at which time dietary intake, current medications and supplements, other medical diagnoses, and coagulation will be evaluated.

Study Type

Observational

Enrollment (Actual)

69

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

  • United States
    • Washington
      • Kenmore, Washington, United States, 98028
        • Bastyr University Clinical Research Center

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population will be sixty (60) individuals with diagnosed or probable multiple sclerosis, verified by board certified neurologist, and forty (40) age and sex matched healthy controls.

Description

Inclusion Criteria:

  • Diagnosis of clinically probable of clinically definite multiple sclerosis made by board certified neurologist. Subject must be willing to release medical information regarding diagnosis
  • Controls must consider themselves healthy and be free of any neurological, autoimmune, endocrine or other chronic disease. Must also be free of any recent acute illness/injury that can influence inflammatory activity.
  • Individuals must be 18 or older

Exclusion Criteria:

  • Diagnosis of coagulation defect
  • Use of anticoagulants (eg. warfarin, coumadin) or Aspirin within 30 days of entry.
  • NSAID within 7 days of entry (dietary intake of fish oil or tumeric is acceptable)
  • Pregnancy

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

Cohorts and Interventions

Group / Cohort
Multiple Sclerosis
Subjects who have been diagnosed with clinically definite or probable multiple sclerosis as defined and recorded by board certified neurologist.
Healthy controls
Adults age 18 and older who have not been diagnosed with any neurological, endocrine, or other chronic health condition. They must also be free of any recent acute illness that can impact inflammation/clotting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sonoclot Coagulation Spectrum (Sonoclot Signature)
Time Frame: Day 1
The Sonoclot Coagulation Spectrum represents a combination of coagulation parameters, including activated clotting time, clot rate, time to peak, and peak amplitude. The mean value of all contributing parameters will be compared between cases and controls.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASA24 omega-3 fatty acid intake
Time Frame: 24 hour recall (24 hours prior to study visit)
The ASA24, in combination with a medication history, will be used to evaluate whether omega-3 fatty acid intake is associated with reduced rates of coagulation in either cases or controls.
24 hour recall (24 hours prior to study visit)

Collaborators and Investigators

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

Sponsor

Bastyr University

Investigators

  • Principal Investigator: Laurie K Mischley, ND, Bastyr University - Clinical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (ACTUAL)

October 1, 2012

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (ESTIMATE)

October 22, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BU-12A-1323

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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