The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia (FM) Symptoms: A Randomized, Double-blind, Placebo-controlled Exploratory Study.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Dietary Supplement: Omega-3 (oil)
* Dietary Supplement: Fatty Acids (placebo)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Colored olive oil<br> | Dietary Supplement: Fatty Acids (placebo)<br>* 5ml daily with breakfast for 56 days.<br>|
| Active Comparator: Omega-3 (oil)<br> | Dietary Supplement: Omega-3 (oil)<br>* 5ml daily with breakfast for 56 days.<br>* Other names: NutraSea HP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) | Pain intensity | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of rescue medication |  | 2 months | 
| Visual analog scales (VAS) | Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion. | 2 months | 
| Fibromyalgia Impact Questionnaire |  | 2 months | 
| Profile of Mood States (POMS) |  | 2 months | 
| Multidimensional Fatigue Inventory (MFI-20) |  | 2 months | 
| Beck Depression Inventory (BDI) |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3, Chronic Pain, Fatigue, Mood, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), Fibromyalgia