FibromyalgiaPhase 2NCT01352013
The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms
A Phase 2 study testing Omega-3 (oil) in people with Fibromyalgia, run by Dr. Yoram Shir at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Omega-3 (oil)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Montreal General Hospital - Alan Edwards Pain Management Unit
Montreal, Quebec, H3G 1A4
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- Omega-3 (oil), Fatty Acids (placebo)
- Keywords
- Fibromyalgia, Omega-3, Chronic Pain, Fatigue, Mood, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA)
- Medical subject headings
- Fibromyalgia, Chronic Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 (oil)Dietary supplement
Also called NutraSea HP
5ml daily with breakfast for 56 days.
Fatty Acids (placebo)Dietary supplement
5ml daily with breakfast for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| Colored olive oil | Placebo comparator | Not described Receives: Dietary Supplement: Fatty Acids (placebo) |
| Omega-3 (oil) | Active comparator | Not described Receives: Dietary Supplement: Omega-3 (oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
Pain intensity
Measured: 2 months
Secondary outcomes (6)
Use of rescue medication
Measured: 2 months
Visual analog scales (VAS)
Changes in levels of patients' pain unpleasantness, fatigue, sleep quality, mood and mental confusion.
Measured: 2 months
Fibromyalgia Impact Questionnaire
Measured: 2 months
Profile of Mood States (POMS)
Measured: 2 months
Multidimensional Fatigue Inventory (MFI-20)
Measured: 2 months
Beck Depression Inventory (BDI)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Yoram Shir
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Responsible party
- Sponsor-investigator, Dr. Yoram Shir, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Yoram Shir, MD, Principal investigator, MUHC - Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352013
- Sponsor's protocol ID
- Omega3-MGH
- Status last verified
- Apr 2015
- First submitted
- 10 May 2011
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia (FM) Symptoms: A Randomized, Double-blind, Placebo-controlled Exploratory Study.
- ClinicalTrials.gov ID
- NCT01352013
- Acronym / sponsor ID
- Omega3-MGH
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Omega-3, Chronic Pain, Fatigue, Mood, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dr. Yoram ShirUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colored olive oil | Placebo comparator | Dietary Supplement: Fatty Acids (placebo) |
| Omega-3 (oil) | Active comparator | Dietary Supplement: Omega-3 (oil) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 (oil)Also: NutraSea HP5ml daily with breakfast for 56 days. | Dietary supplement | Omega-3 (oil) |
| Fatty Acids (placebo)5ml daily with breakfast for 56 days. | Dietary supplement | Colored olive oil |
Primary outcome
Visual analog scale (VAS)
Time frame: 2 months
Pain intensity
6 secondary outcomes
Use of rescue medication
Time frame: 2 months
Visual analog scales (VAS)
Time frame: 2 months
Fibromyalgia Impact Questionnaire
Time frame: 2 months
Profile of Mood States (POMS)
Time frame: 2 months
Multidimensional Fatigue Inventory (MFI-20)
Time frame: 2 months
Beck Depression Inventory (BDI)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoram Shir, MD principal investigator
MUHC - Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 (oil) in people with Fibromyalgia, run by Dr. Yoram Shir at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.