The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms
This study is ongoing, but not recruiting participants.
Sponsor:
Dr. Yoram Shir
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
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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
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 |
Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015