Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01352013
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : April 16, 2015
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
Dr. Yoram Shir, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352013


Locations
Layout table for location information
Canada, Quebec
Montreal General Hospital - Alan Edwards Pain Management Unit
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Dr. Yoram Shir
McGill University
Investigators
Layout table for investigator information
Principal Investigator: Yoram Shir, MD MUHC - Research Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr. Yoram Shir, Doctor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01352013    
Other Study ID Numbers: Omega3-MGH
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by Dr. Yoram Shir, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Fibromyalgia
Omega-3
Chronic Pain
Fatigue
 Mood
docosahexaenoic acid (DHA)
eicosapentaenoic acid (EPA)
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases