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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01352013
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : April 16, 2015
McGill University
Information provided by (Responsible Party):
Dr. Yoram Shir, McGill University Health Center

May 10, 2011
May 11, 2011
April 16, 2015
January 2012
September 2013   (Final data collection date for primary outcome measure)
Visual analog scale (VAS) [ Time Frame: 2 months ]
Pain intensity
Same as current
Complete list of historical versions of study NCT01352013 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms
The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia (FM) Symptoms: A Randomized, Double-blind, Placebo-controlled Exploratory Study.
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Dietary Supplement: Omega-3 (oil)
    5ml daily with breakfast for 56 days.
    Other Name: NutraSea HP
  • Dietary Supplement: Fatty Acids (placebo)
    5ml daily with breakfast for 56 days.
  • Placebo Comparator: Colored olive oil
    Intervention: Dietary Supplement: Fatty Acids (placebo)
  • Active Comparator: Omega-3 (oil)
    Intervention: Dietary Supplement: Omega-3 (oil)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
September 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr. Yoram Shir, McGill University Health Center
Dr. Yoram Shir
McGill University
Principal Investigator: Yoram Shir, MD MUHC - Research Institute
McGill University Health Center
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP