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

Purpose

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	Intervention	Phase
Fibromyalgia	Dietary Supplement: Omega-3 (oil) Dietary Supplement: Fatty Acids (placebo)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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.

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Fibromyalgia

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Dr. Yoram Shir, McGill University Health Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	19
Study Start Date:	January 2012
Study Completion Date:	December 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352013

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


Responsible Party:	Dr. Yoram Shir, Doctor, McGill University Health Center
ClinicalTrials.gov Identifier:	NCT01352013 History of Changes
Other Study ID Numbers:	Omega3-MGH
Study First Received:	May 10, 2011
Last Updated:	April 15, 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

ClinicalTrials.gov processed this record on July 24, 2017