Evaluation of Coagulation in Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01711255
• Lead Sponsor: Bastyr University

Brief Summary

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

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-22
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sonoclot Coagulation Spectrum (Sonoclot Signature)	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.

Secondary Outcome Measures

Name	Time	Method
ASA24 omega-3 fatty acid intake	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.

Trial Locations

Locations (1)

Bastyr University Clinical Research Center; 🇺🇸 Kenmore, Washington, United States