Novel Immune Markers in Patients With Multiple Sclerosis (NIMMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01026272
First received: December 2, 2009
Last updated: July 9, 2010
Last verified: July 2010
  Purpose

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


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantification of Novel Immune Markers in Human Serum of Patients With MS

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Quantification of endogenous cannabinoids [ Time Frame: one time blood draw ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monocyte migration [ Time Frame: one time blood draw ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy subjects
subjects with no sign of inflammatory disease, or diagnosis of MS
Patients with MS

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with Multiple Sclerosis

Criteria

Inclusion Criteria:

Inclusion Criteria for MS patients:

  1. 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.
  2. Not currently in "relapse" or exacerbation.
  3. Age > 21 and < 50.
  4. Subjects must be able to attend study visits at screening, baseline and time points of 4, 12 and 24 weeks.
  5. Diet, exercise, and supplementation must be kept constant throughout participation in the study.
  6. Ability to read and speak English.

Inclusion criteria for healthy subjects:

  1. Current.
  2. Age > 21 and < 50.
  3. Subjects must be able to attend study visits at screening, baseline and time points 4, 12 and 24 weeks.
  4. Diet, exercise, and supplementation must be kept constant throughout participation in the study.
  5. Ability to read and speak English.

Exclusion Criteria:

  1. Supplementation with fish oils in the last six months.
  2. 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).
  3. Hormone Replacement Therapy or oral contraception pills or pregnancy.
  4. Use of clinical Cannabis for MS symptom control or recreationally in the last 6 months.
  5. Previous diagnosis of DSMV criteria.
  6. Use of tobacco, either orally or inhaled.
  7. BMI >27 or <19.
  8. Diagnosis of Diabetes (fasting blood sugar over 125 mg/dl).
  9. Performance athletes.
  10. Medical history/diagnosis of autoimmune or other chronic inflammatory disease or serious immunologically-related health condition.
  11. Lactose intolerance (in-ability to eat/drink milk products without problems).
  12. 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.
  13. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026272

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98028
Contact: Michelle Sexton, ND    206-538-3896    msexton@uw.edu   
Principal Investigator: Michelle Sexton, ND         
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Michelle Sexton, ND    206-543-3896    msexton@uw.edu   
Principal Investigator: Michelle Sexton, ND         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Michelle Sexton, ND University of Washington
  More Information

No publications provided

Responsible Party: Michelle Sexton ND, University of Washington
ClinicalTrials.gov Identifier: NCT01026272     History of Changes
Other Study ID Numbers: 35083-B, A50879
Study First Received: December 2, 2009
Last Updated: July 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Endocannabinoid
Fish Oil
Multiple Sclerosis
Monocyte Migration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014