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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
Dr. Yoram Shir, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01352013
First received: May 10, 2011
Last updated: July 26, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Visual analog scale (VAS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Pain intensity


Secondary Outcome Measures:
  • Use of rescue medication [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Visual analog scales (VAS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion.

  • Fibromyalgia Impact Questionnaire [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Profile of Mood States (POMS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Multidimensional Fatigue Inventory (MFI-20) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated 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
Genders 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

No publications provided

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: July 26, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by 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 26, 2014