Skip to content

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)

FacilityCityProvince
Montreal General Hospital - Alan Edwards Pain Management UnitMontrealQuebec

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01352013