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

NCT ID: NCT01352013

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-12-31

Brief Summary

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Colored olive oil

Group Type: PLACEBO_COMPARATOR

Fatty Acids (placebo)

Intervention Type: DIETARY_SUPPLEMENT

5ml daily with breakfast for 56 days.

Omega-3 (oil)

Group Type: ACTIVE_COMPARATOR

Omega-3 (oil)

Intervention Type: DIETARY_SUPPLEMENT

5ml daily with breakfast for 56 days.

Interventions

Omega-3 (oil)

5ml daily with breakfast for 56 days.

Intervention Type: DIETARY_SUPPLEMENT

Fatty Acids (placebo)

5ml daily with breakfast for 56 days.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

NutraSea HP

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

Dr. Yoram Shir

OTHER

Sponsor Role: lead

Responsible Party

Dr. Yoram Shir

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yoram Shir, MD

Role: PRINCIPAL_INVESTIGATOR

MUHC - Research Institute

Locations

Montreal General Hospital - Alan Edwards Pain Management Unit

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

Omega3-MGH

Identifier Type: -

Identifier Source: org_study_id