Skip to main content
OpenTrials
Completed

NCT Number: NCT01711255

Evaluation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cardiovascular Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Embolism and Thrombosis Immune System Diseases Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bastyr University Clinical Research Center

Kenmore, Washington, 98028, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bastyr University

Other

Registry information

Official study title

A Cross-Sectional Study of Coagulation in Multiple Sclerosis

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 22, 2012
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.