Clinical trial NCT01352013: The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms
Official title: The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia (FM) Symptoms: A Randomized, Double-blind, Placebo-controlled Exploratory Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Omega-3
Chronic Pain
Fatigue
Mood
docosahexaenoic acid (DHA)
eicosapentaenoic acid (EPA)
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2011-05-11
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if omega-3 fatty acid supplements are more effective than an inactive placebo at reducing pain, reducing fatigue and elevating mood in patients with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-65.
* A diagnosis of FM according to the American College of Rheumatology classification criteria(Wolfe et al., 1990)
* Negative urine pregnancy test at enrolment and willingness not to become pregnant for the duration of the study.
* Pain levels of at least 4 on 10-cm VAS at the time of recruitment.
* Ability to communicate in English or in French.
* Willing to sign an informed consent.
* If the patient is taking medication or natural health product (excluding omega-3 containing products) to treat fibromyalgia, she must be on a stable regimen for a minimum of two weeks before recruitment and be willing to keep this stable medication or natural health product regimen throughout the study period.
* If the patient is using other therapies to treat fibromyalgia such as TENS, acupuncture, exercise, psychotherapy, massage, physiotherapy, etc, she must be doing so for a minimum of two weeks before recruitment and be willing to continue those therapies throughout the study period.

Exclusion Criteria:

* Use of anticoagulants (Coumadin® or Plavix®), having a bleeding disorder or being scheduled for a surgical procedure. This is because omega-3 fatty acids can prolong bleeding time, although doses we propose to use are safe (see Risks section)
* Allergy to fish, olive oil, medium chain triglycerides, lemon, green tea, vitamin E or tylenol
* Past (within the last year) or present specific dietary supplementation with omega-3 fish oil or other natural health products containing omega-3 fatty acids (e.g. flax seed oil, krill oil, etc) or regularly eating more than two fatty fish meals/week (salmon, mackerel, sardine, flounder, herring, or any other fish considered to have a high level of omega-3 fatty acids).
* Patient enrolled in another research study involving any treatment.
* Patient engaged in active litigation
* Regular use of recreational drugs
* Alcohol consumption \> 10 units/week
* Morbidly obese patients
* Pregnancy or breastfeeding
* Uncontrolled major medical conditions. Neurological problems. Current psychiatric condition. Chronic pain condition other than FM.

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 2 months
Secondary outcomes:
measure: Use of rescue medication
timeFrame: 2 months
measure: Visual analog scales (VAS)
timeFrame: 2 months
measure: Fibromyalgia Impact Questionnaire
timeFrame: 2 months
measure: Profile of Mood States (POMS)
timeFrame: 2 months
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: 2 months
measure: Beck Depression Inventory (BDI)
timeFrame: 2 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital - Alan Edwards Pain Management Unit
state: Quebec
Study officials:
affiliation: MUHC - Research Institute
name: Yoram Shir, MD
role: PRINCIPAL_INVESTIGATOR
References: