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

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Omega-3 (oil)

Fatty Acids (placebo)

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Omega-3, Chronic Pain, Fatigue, Mood, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Montreal General Hospital - Alan Edwards Pain Management Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Colored olive oil

Omega-3 (oil)

Arm Description

Outcomes

Primary Outcome Measures

Visual analog scale (VAS)

Pain intensity

Secondary Outcome Measures

Use of rescue medication

Visual analog scales (VAS)

Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion.

Fibromyalgia Impact Questionnaire

Profile of Mood States (POMS)

Multidimensional Fatigue Inventory (MFI-20)

Beck Depression Inventory (BDI)

Full Information

NCT ID

NCT01352013

First Posted

May 10, 2011

Last Updated

April 15, 2015

Sponsor

Dr. Yoram Shir

Collaborators

McGill University

1. Study Identification

Unique Protocol Identification Number

NCT01352013

Brief Title

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

Official Title

The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia (FM) Symptoms: A Randomized, Double-blind, Placebo-controlled Exploratory Study.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Yoram Shir

Collaborators

McGill University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Omega-3, Chronic Pain, Fatigue, Mood, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Colored olive oil

Arm Type

Placebo Comparator

Arm Title

Omega-3 (oil)

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3 (oil)

Other Intervention Name(s)

NutraSea HP

Intervention Description

5ml daily with breakfast for 56 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

Fatty Acids (placebo)

Intervention Description

5ml daily with breakfast for 56 days.

Primary Outcome Measure Information:

Title

Visual analog scale (VAS)

Description

Pain intensity

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Use of rescue medication

Time Frame

2 months

Title

Visual analog scales (VAS)

Description

Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion.

Time Frame

2 months

Title

Fibromyalgia Impact Questionnaire

Time Frame

2 months

Title

Profile of Mood States (POMS)

Time Frame

2 months

Title

Multidimensional Fatigue Inventory (MFI-20)

Time Frame

2 months

Title

Beck Depression Inventory (BDI)

Time Frame

2 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoram Shir, MD

Organizational Affiliation

MUHC - Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montreal General Hospital - Alan Edwards Pain Management Unit

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

12. IPD Sharing Statement

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

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