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

This study has been completed.
McGill University
Information provided by (Responsible Party):
Dr. Yoram Shir, McGill University Health Center Identifier:
First received: May 10, 2011
Last updated: April 15, 2015
Last verified: April 2015
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.

Condition Intervention Phase
Fibromyalgia Dietary Supplement: Omega-3 (oil) Dietary Supplement: Fatty Acids (placebo) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia (FM) Symptoms: A Randomized, Double-blind, Placebo-controlled Exploratory Study.

Resource links provided by NLM:

Further study details as provided by Dr. Yoram Shir, McGill University Health Center:

Primary Outcome Measures:
  • Visual analog scale (VAS) [ Time Frame: 2 months ]
    Pain intensity

Secondary Outcome Measures:
  • Use of rescue medication [ Time Frame: 2 months ]
  • Visual analog scales (VAS) [ Time Frame: 2 months ]
    Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion.

  • Fibromyalgia Impact Questionnaire [ Time Frame: 2 months ]
  • Profile of Mood States (POMS) [ Time Frame: 2 months ]
  • Multidimensional Fatigue Inventory (MFI-20) [ Time Frame: 2 months ]
  • Beck Depression Inventory (BDI) [ Time Frame: 2 months ]

Enrollment: 19
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Colored olive oil Dietary Supplement: Fatty Acids (placebo)
5ml daily with breakfast for 56 days.
Active Comparator: Omega-3 (oil) Dietary Supplement: Omega-3 (oil)
5ml daily with breakfast for 56 days.
Other Name: NutraSea HP


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01352013

Canada, Quebec
Montreal General Hospital - Alan Edwards Pain Management Unit
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Dr. Yoram Shir
McGill University
Principal Investigator: Yoram Shir, MD MUHC - Research Institute
  More Information

Responsible Party: Dr. Yoram Shir, Doctor, McGill University Health Center Identifier: NCT01352013     History of Changes
Other Study ID Numbers: Omega3-MGH
Study First Received: May 10, 2011
Last Updated: April 15, 2015

Keywords provided by Dr. Yoram Shir, McGill University Health Center:
Chronic Pain
docosahexaenoic acid (DHA)
eicosapentaenoic acid (EPA)

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases processed this record on September 21, 2017