Evaluation of Coagulation in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

A Cross-Sectional Study of Coagulation in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711255
• Other study ID #: BU-12A-1323
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: July 27, 2017
• Start date: October 2012
• Est. completion date: May 2016

Study information

• Verified date: July 2017
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Bastyr University Clinical Research Center	Kenmore	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bastyr University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sonoclot Coagulation Spectrum (Sonoclot Signature)	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	ASA24 omega-3 fatty acid intake	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)

External Links

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