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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Dietary supplement: Fatty Acids (placebo); Dietary supplement: Omega-3 (oil)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital - Alan Edwards Pain Management Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: NutraSea HP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS)	Pain intensity	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of rescue medication		2 months
Visual analog scales (VAS)	Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion.	2 months
Fibromyalgia Impact Questionnaire		2 months
Profile of Mood States (POMS)		2 months
Multidimensional Fatigue Inventory (MFI-20)		2 months
Beck Depression Inventory (BDI)		2 months

Collaborators and Investigators

• Sponsor: Dr. Yoram Shir
• Collaborators: McGill University
• Investigators: Principal Investigator: Yoram Shir, MD, MUHC - Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 10, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): April 16, 2015
• Last Update Submitted That Met QC Criteria: April 15, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Chronic Pain; Fatigue; Fibromyalgia; Omega-3; Mood; docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA)
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Omega3-MGH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No