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Completed

NCT Number: NCT01352013

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Montreal General Hospital - Alan Edwards Pain Management Unit

Montreal, Quebec, H3G 1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3 (oil)

Dietary Supplement

5ml daily with breakfast for 56 days.

Other names: NutraSea HP

Fatty Acids (placebo)

Dietary Supplement

5ml daily with breakfast for 56 days.

Primary outcomes

  1. Visual analog scale (VAS)

    Time frame: 2 months

    Pain intensity

Secondary outcomes

  1. Use of rescue medication

    Time frame: 2 months

  2. Visual analog scales (VAS)

    Time frame: 2 months

    Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion.

  3. Fibromyalgia Impact Questionnaire

    Time frame: 2 months

  4. Profile of Mood States (POMS)

    Time frame: 2 months

  5. Multidimensional Fatigue Inventory (MFI-20)

    Time frame: 2 months

  6. Beck Depression Inventory (BDI)

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Dr. Yoram Shir

Other

Collaborators

  • McGill University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 11, 2011
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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