Evaluation of Coagulation in Multiple Sclerosis

A Cross-Sectional Study of Coagulation in Multiple Sclerosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01711255

Enrollment

Registered

2012-10-22

Start date

2012-10-31

Completion date

2016-05-31

Last updated

2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Coagulation, Alternative Medicine, Clotting, Complementary Medicine, Inflammation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results