Clinical trial NCT01026272: Novel Immune Markers in Patients With Multiple Sclerosis
Official title: Quantification of Novel Immune Markers in Human Serum of Patients With MS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Endocannabinoid
Fish Oil
Multiple Sclerosis
Monocyte Migration
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Multiple Sclerosis

Brief 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. 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


Eligibility 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.

Primary outcomes:
measure: Quantification of endogenous cannabinoids
timeFrame: one time blood draw
Secondary outcomes:
measure: Monocyte migration
timeFrame: one time blood draw
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Michelle Sexton, ND
role: PRINCIPAL_INVESTIGATOR
References: