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

May 10, 2011
July 26, 2013
January 2012
September 2013   (final data collection date for primary outcome measure)
Visual analog scale (VAS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Pain intensity
Same as current
Complete list of historical versions of study NCT01352013 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms
The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia (FM) Symptoms: A Randomized, Double-blind, Placebo-controlled Exploratory Study.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Dietary Supplement: Omega-3 (oil)
    5ml daily with breakfast for 56 days.
    Other Name: NutraSea HP
  • Dietary Supplement: Fatty Acids (placebo)
    5ml daily with breakfast for 56 days.
  • Placebo Comparator: Colored olive oil
    Intervention: Dietary Supplement: Fatty Acids (placebo)
  • Active Comparator: Omega-3 (oil)
    Intervention: Dietary Supplement: Omega-3 (oil)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2013
September 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01352013
Omega3-MGH
No
Dr. Yoram Shir, McGill University Health Center
Dr. Yoram Shir
McGill University
Principal Investigator: Yoram Shir, MD MUHC - Research Institute
McGill University Health Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP