NCT01352013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

May 10, 2011

Last Update Submit

April 15, 2015

Conditions

Fibromyalgia

Keywords

FibromyalgiaOmega-3Chronic PainFatigueMooddocosahexaenoic acid (DHA)eicosapentaenoic acid (EPA)

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale (VAS)

    Pain intensity

    2 months

Secondary Outcomes (6)

  • Use of rescue medication

    2 months

  • Visual analog scales (VAS)

    2 months

  • Fibromyalgia Impact Questionnaire

    2 months

  • Profile of Mood States (POMS)

    2 months

  • Multidimensional Fatigue Inventory (MFI-20)

    2 months

  • +1 more secondary outcomes

Study Arms (2)

Colored olive oil

PLACEBO COMPARATOR
Dietary Supplement: Fatty Acids (placebo)

Omega-3 (oil)

ACTIVE COMPARATOR
Dietary Supplement: Omega-3 (oil)

Interventions

Omega-3 (oil)DIETARY_SUPPLEMENT

5ml daily with breakfast for 56 days.

Also known as: NutraSea HP
Omega-3 (oil)
Fatty Acids (placebo)DIETARY_SUPPLEMENT

5ml daily with breakfast for 56 days.

Colored olive oil

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital - Alan Edwards Pain Management Unit

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

FibromyalgiaChronic PainFatigue

Interventions

Docosahexaenoic AcidsOilsFatty Acids

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFish Oils

Study Officials

  • Yoram Shir, MD

    MUHC - Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 11, 2011

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

CA(1)