The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms
CompletedPhase 2NCT01352013
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
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.
Study details
- Official title
- The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia (FM) Symptoms: A Randomized, Double-blind, Placebo-controlled Exploratory Study.
- Conditions
- Interventions
- Dietary supplement: Omega-3 (oil)
- Dietary supplement: Fatty Acids (placebo)
- Sponsor
- Dr. Yoram Shir
- Collaborators
- McGill University
- Organization
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Start date
- 2012-01
- Primary completion
- 2013-09
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01352013