The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms
This study is currently recruiting participants.
Verified January 2012 by McGill University Health Center
Sponsor:
McGill University Health Center
Collaborator:
Alan Edwards Centre for Research on Pain
Information provided by (Responsible Party):
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01352013
First received: May 10, 2011
Last updated: January 10, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2012 |
| Estimated Primary Completion Date: | September 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352013
Contacts
| Contact: Sylvie Toupin, B.Sc. | 514-934-1934 ext 44348 | sylvie.toupin@mail.mcgill.ca |
| Contact: Linda Ferguson | 514-934-1934 ext 44361 | linda.ferguson@muhc.mcgill.ca |
Locations
| Canada, Quebec | |
| Montreal General Hospital - Alan Edwards Pain Management Unit | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Principal Investigator: Yoram Shir, MD | |
| Sub-Investigator: Mary-Ann Fitzcharles, MD | |
| Sub-Investigator: Mark A Ware, MD | |
Sponsors and Collaborators
McGill University Health Center
Alan Edwards Centre for Research on Pain
Investigators
| Principal Investigator: | Yoram Shir, MD | MUHC - Research Institute |
More Information
No publications provided
| Responsible Party: | 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: | January 10, 2012 |
| 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 May 16, 2013