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Evaluation of Coagulation in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01711255
Recruitment Status : Completed
First Posted : October 22, 2012
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Multiple Sclerosis

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.

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Cross-Sectional Study of Coagulation in Multiple Sclerosis
Actual Study Start Date : October 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Six (6) whole blood vials of 10ml each will be collected from each subject. Three (3) will be stored for future use. Three will be used immediately for coagulation analysis using Sonoclot.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will be sixty (60) individuals with diagnosed or probable multiple sclerosis, verified by board certified neurologist, and forty (40) age and sex matched healthy controls.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711255


Locations
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United States, Washington
Bastyr University Clinical Research Center
Kenmore, Washington, United States, 98028
Sponsors and Collaborators
Bastyr University
Investigators
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Principal Investigator: Laurie K Mischley, ND Bastyr University - Clinical Research Center

Additional Information:
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Responsible Party: Bastyr University
ClinicalTrials.gov Identifier: NCT01711255     History of Changes
Other Study ID Numbers: BU-12A-1323
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Keywords provided by Bastyr University:
Multiple sclerosis
Coagulation
Alternative Medicine
Clotting
Complementary Medicine
Inflammation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases