Multiple SclerosisNIMMSNCT01026272
Novel Immune Markers in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University of Washington at 2 sites in United States.
Trial summary
The investigators hypothesize that the endogenous cannabinoid signalling system has lost homeostasis in the disease multiple sclerosis (MS). To investigate a novel action of dietary fish oils, the investigators will administer a food frequency questionnaire to both healthy subjects and patients with MS. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to May 2011
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with Multiple Sclerosis
Who may be able to join
- Diagnosis of Multiple Sclerosis (relapsing, remitting) made by a clinical neurologist within the previous 5 years by either MRI (> 3 white matter lesions) or score of 3-5 on the Kurtzke Expanded Disability Status Scale.
- Not currently in "relapse" or exacerbation.
- Age > 21 and < 50.
- Subjects must be able to attend study visits at screening, baseline and time points of 4, 12 and 24 weeks.
- Diet, exercise, and supplementation must be kept constant throughout participation in the study.
- Ability to read and speak English.
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- Current.
- Age > 21 and < 50.
- Subjects must be able to attend study visits at screening, baseline and time points 4, 12 and 24 weeks.
- Diet, exercise, and supplementation must be kept constant throughout participation in the study.
- Ability to read and speak English.
Who cannot join
- Supplementation with fish oils in the last six months.
- Diagnosis of any bleeding disorder (hemophilia, vonWillebrands, menorrhagia, hypercoaguability, history of clots, thrombocytopenia). Any patient with one of these diagnoses and/or any patient on any of/combination of the following medications would not be eligible for participation: ANTICOAGULANT/ANTIPLATELET DRUGS: Some of these drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin).
- Hormone Replacement Therapy or oral contraception pills or pregnancy.
- Use of clinical Cannabis for MS symptom control or recreationally in the last 6 months.
- Previous diagnosis of DSMV criteria.
- Use of tobacco, either orally or inhaled.
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- BMI >27 or <19.
- Diagnosis of Diabetes (fasting blood sugar over 125 mg/dl).
- Performance athletes.
- Medical history/diagnosis of autoimmune or other chronic inflammatory disease or serious immunologically-related health condition.
- Lactose intolerance (in-ability to eat/drink milk products without problems).
- Allergy to fish or seafood. Theoretically, some people who are allergic to seafood such as fish might also be allergic to fish oil supplements. There is no reliable information showing how likely people with seafood allergy are to have an allergic reaction to fish oils; however, until more is known advise patients allergic to seafood to avoid or use fish oil supplements cautiously.
- High dose supplement/botanical therapy which may have an effect on bleeding times: Vitamin E (greater than 400 IU/qd); adn/or daily use of any/combination of the following botanical therapy: Angelica sinensis; Allium sativum; Zingiber officinale; Ginkgo biloba; and Salix alba.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98028
Michelle Sexton, ND, 206-538-3896, msexton@uw.edu
Michelle Sexton, ND
- Recruiting
University of Washington
Seattle, Washington, 98195
Michelle Sexton, ND, 206-543-3896, msexton@uw.edu
Michelle Sexton, ND
About this study
Official title: Quantification of Novel Immune Markers in Human Serum of Patients With MS
The investigators hypothesize that the endogenous cannabinoid signalling system has lost homeostasis in the disease multiple sclerosis (MS). To investigate a novel action of dietary fish oils, the investigators will administer a food frequency questionnaire to both healthy subjects and patients with MS. The investigators will first determine if there are differences between both populations of endogenous cannabinoids, and then determine whether dietary intake of fish oils alters these levels
- Conditions
- Multiple Sclerosis
- Keywords
- Endocannabinoid, Fish Oil, Multiple Sclerosis, Monocyte Migration
- Medical subject headings
- Multiple Sclerosis
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 |
|---|---|---|
| healthy subjects | subjects with no sign of inflammatory disease, or diagnosis of MS | |
| Patients with MS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of endogenous cannabinoids
Measured: one time blood draw
Secondary outcomes (1)
Monocyte migration
Measured: one time blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
- Study completionMay 2011 (estimated)
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.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Michelle Sexton, ND, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026272
- Sponsor's protocol ID
- 35083-B
- Other IDs
- A50879
- Acronym
- NIMMS
- Status last verified
- Jul 2010
- First submitted
- 2 Dec 2009
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Novel Immune Markers in Human Serum of Patients With MS
- ClinicalTrials.gov ID
- NCT01026272
- Acronym / sponsor ID
- NIMMS / 35083-B
- Conditions
- Multiple Sclerosis
- Keywords
- Endocannabinoid, Fish Oil, Multiple Sclerosis, Monocyte Migration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 4 Dec 2009 (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.
The investigators hypothesize that the endogenous cannabinoid signalling system has lost homeostasis in the disease multiple sclerosis (MS). To investigate a novel action of dietary fish oils, the investigators will administer a food frequency questionnaire to both healthy subjects and patients with MS. The investigators will first determine if there are differences between both populations of endogenous cannabinoids, and then determine whether dietary intake of fish oils alters these levels
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | – | –subjects with no sign of inflammatory disease, or diagnosis of MS |
| Patients with MS | – | – |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with Multiple Sclerosis
Key inclusion criteria (11 listed)
- Diagnosis of Multiple Sclerosis (relapsing, remitting) made by a clinical neurologist within the previous 5 years by either MRI (> 3 white matter lesions) or score of 3-5 on the Kurtzke Expanded Disability Status Scale.
- Not currently in "relapse" or exacerbation.
- Age > 21 and < 50.
- Subjects must be able to attend study visits at screening, baseline and time points of 4, 12 and 24 weeks.
- Diet, exercise, and supplementation must be kept constant throughout participation in the study.
Key exclusion criteria (13 listed)
- Supplementation with fish oils in the last six months.
- Diagnosis of any bleeding disorder (hemophilia, vonWillebrands, menorrhagia, hypercoaguability, history of clots, thrombocytopenia). Any patient with one of these diagnoses and/or any patient on any of/combination of the following medications would not be eligible for participation: ANTICOAGULANT/ANTIPLATELET DRUGS: Some of these drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin).
- Hormone Replacement Therapy or oral contraception pills or pregnancy.
- Use of clinical Cannabis for MS symptom control or recreationally in the last 6 months.
- Previous diagnosis of DSMV criteria.
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
Quantification of endogenous cannabinoids
Time frame: one time blood draw
1 secondary outcome
Monocyte migration
Time frame: one time blood draw
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2010.
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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.
Michelle Sexton, ND principal investigator
University of Washington
2 sites 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 University of Washington at 2 sites 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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of endogenous cannabinoids (time frame: one time blood draw). 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 13 Jul 2010.