Multiple SclerosisNCT01711255
Evaluation of Coagulation in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Bastyr University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bastyr University Clinical Research Center
Kenmore, Washington, 98028
About this study
Official title: A Cross-Sectional Study 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Coagulation, Alternative Medicine, Clotting, Complementary Medicine, Inflammation
- Medical subject headings
- Multiple Sclerosis, Thrombosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: 24 hour recall (24 hours prior to study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie K Mischley, ND, Principal investigator, Bastyr University - Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711255
- Sponsor's protocol ID
- BU-12A-1323
- Status last verified
- Jul 2017
- First submitted
- 17 Oct 2012
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study of Coagulation in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01711255
- Acronym / sponsor ID
- BU-12A-1323
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Coagulation, Alternative Medicine, Clotting, Complementary Medicine, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
ASA24 omega-3 fatty acid intake
Time frame: 24 hour recall (24 hours prior to study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Related infoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie K Mischley, ND principal investigator
Bastyr University - Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bastyr University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonoclot Coagulation Spectrum (Sonoclot Signature) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.