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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352013
• Other study ID #: Omega3-MGH
• Status: Completed
• Phase: Phase 2
• First received: May 10, 2011
• Last updated: April 15, 2015
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• Omega-3 (oil)
5ml daily with breakfast for 56 days.
• Fatty Acids (placebo)
5ml daily with breakfast for 56 days.

Locations

Country	Name	City	State
Canada	Montreal General Hospital - Alan Edwards Pain Management Unit	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Yoram Shir	McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS)	Pain intensity	2 months	No
Secondary	Use of rescue medication		2 months	No
Secondary	Visual analog scales (VAS)	Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion.	2 months	No
Secondary	Fibromyalgia Impact Questionnaire		2 months	No
Secondary	Profile of Mood States (POMS)		2 months	No
Secondary	Multidimensional Fatigue Inventory (MFI-20)		2 months	No
Secondary	Beck Depression Inventory (BDI)		2 months	No