The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms
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ClinicalTrials.gov Identifier: NCT01352013 |
Recruitment Status :
Completed
First Posted : May 11, 2011
Last Update Posted : April 16, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia | Dietary Supplement: Omega-3 (oil) Dietary Supplement: Fatty Acids (placebo) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
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. |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
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 |
- Visual analog scale (VAS) [ Time Frame: 2 months ]Pain intensity
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352013
Canada, Quebec | |
Montreal General Hospital - Alan Edwards Pain Management Unit | |
Montreal, Quebec, Canada, H3G 1A4 |
Principal Investigator: | Yoram Shir, MD | MUHC - Research Institute |
Responsible Party: | Dr. Yoram Shir, Doctor, McGill University Health Centre/Research Institute of the McGill University Health Centre |
ClinicalTrials.gov Identifier: | NCT01352013 |
Other Study ID Numbers: |
Omega3-MGH |
First Posted: | May 11, 2011 Key Record Dates |
Last Update Posted: | April 16, 2015 |
Last Verified: | April 2015 |
Fibromyalgia Omega-3 Chronic Pain Fatigue |
Mood docosahexaenoic acid (DHA) eicosapentaenoic acid (EPA) |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |