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

Dr. Yoram Shir

Status and phase

Completed

Phase 2

Conditions

Fibromyalgia

Treatments

Dietary Supplement: Fatty Acids (placebo)

Dietary Supplement: Omega-3 (oil)

Study type

Interventional

Funder types

Other

Identifiers

NCT01352013

Omega3-MGH

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.