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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Dietary Supplement: Omega-3 (oil); Dietary Supplement: Fatty Acids (placebo)	Phase 2

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Visual analog scale (VAS) [ Time Frame: 2 months ]
   Pain intensity

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Dr. Yoram Shir

McGill University

Investigators

Principal Investigator:	Yoram Shir, MD	MUHC - Research Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Yoram Shir, Doctor, McGill University Health Center
ClinicalTrials.gov Identifier:	NCT01352013 History of Changes
Other Study ID Numbers:	Omega3-MGH
First Posted:	May 11, 2011
Last Update Posted:	April 16, 2015
Last Verified:	April 2015

Keywords provided by Dr. Yoram Shir, McGill University Health Center:

Fibromyalgia; Omega-3; Chronic Pain; Fatigue	Mood; docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA)

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases	Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases