Evaluation of Coagulation in Multiple Sclerosis

NCT ID: NCT01711255

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Multiple Sclerosis

Subjects who have been diagnosed with clinically definite or probable multiple sclerosis as defined and recorded by board certified neurologist.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bastyr University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurie K Mischley, ND

Role: PRINCIPAL_INVESTIGATOR

Bastyr University - Clinical Research Center

Locations

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Bastyr University Clinical Research Center

Kenmore, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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BU-12A-1323

Identifier Type: -

Identifier Source: org_study_id

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