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Influence of an Omega-3 SPM Supplement on Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683850
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Metagenics, Inc.
Information provided by (Responsible Party):
Ryan Bradley, National University of Natural Medicine

Brief Summary:
This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™ soft gel supplement for four weeks will increase the quality of life in adults with chronic pain.

Condition or disease Intervention/treatment Phase
Chronic Pain Dietary Supplement: Omega-3 SPM™ softgel Early Phase 1

Detailed Description:

One third of the America population is affected by chronic pain. The societal costs associated with chronic pain is up to $635 billion dollars annually. Prescribed pain medications may have negative side effects, or cause addictions. Having alternative treatments that can reduce inflammation and the side effects associated with chronic pain may improve the quality of life for millions.

This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™ soft gel supplement for four weeks will increase the quality of life in adults with chronic pain. SPM™ softgels are a dietary supplement intended to reduce pain and inflammation. Up to 40 men and women with chronic pain will be recruited. Outcome measures will be collected at baseline, 2 weeks, and 4 weeks with a primary endpoint of 4 weeks. The primary outcomes of this pilot study include questionnaires to assess quality of life. Exploratory outcomes assess safety and tolerability, changes in anxiety and depression as well as levels of pain, and blood markers associated with inflammation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influence of an Omega-3 SPM Supplement on Quality of Life
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Omega-3 SPM

Intervention: Study participants will be instructed to take 3 Omega-3 SPM™ softgel supplements in the morning and 3 Omega-3 SPM™ soft gel supplements in the evening for two weeks.

At weeks two participants whose PROMIS-43 Pain Intensity score indicates a reduction in pain levels weeks, will take 2 Omega-3 SPM™ soft gel supplements in the morning and 2 in the evening for the remaining 2 weeks of the study.

Participants whose PROMIS-43 Pain Intensity score remained the same after two weeks, or increased will take 4 Omega-3 SPM™ soft gel supplements in the morning and 4 SPM™ softgels in the evening for the remaining two weeks of the study.

Dietary Supplement: Omega-3 SPM™ softgel
This four week, prospective, non-randomized, open-label study is assessing the impact on quality of life from taking an Omega-3 SPM™ softgel supplement in adults with pain symptoms at screening of 4 or higher on the PROMIS-43 Profile - Pain Intensity subscale.




Primary Outcome Measures :
  1. Quality of Life through PROMIS-43 [ Time Frame: Four weeks ]
    To assess the effect of 4 weeks of treatment with a SPM supplement on quality of life in a chronic pain population using the PROMIS-43 Profile (including PROMIS-43 subscales addressing physical function, fatigue, and sleep disturbance, ability to participate in social roles and activities).

  2. Quality of Life ACPA [ Time Frame: Four weeks ]
    To assess the effect of 4 weeks of treatment with a SPM supplement on quality of life in a chronic pain population using American Chronic Pain Association's Quality of Life Scale.


Other Outcome Measures:
  1. ncidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: four weeks ]
    To assess the effect of 4 weeks of treatment with a SPM supplement on safety and tolerability will be monitored by changes in multi-system symptoms using the NCNM Adverse Event Monitoring Form.

  2. Depression and Anxiety PHQ-9 [ Time Frame: four weeks ]
    To assess the effect of 4 weeks of treatment with a SPM supplement on changes in depression and anxiety determined using the PHQ-9

  3. Depression and Anxiety GAD-7 [ Time Frame: four weeks ]
    To assess the effect of 4 weeks of treatment with a SPM supplement on changes in depression and anxiety determined using the GAD-7

  4. Depression and Anxiety PROMIS-43 [ Time Frame: four weeks ]
    To assess the effect of 4 weeks of treatment with a SPM supplement on changes in depression and anxiety determined using the PROMIS-43 Profile

  5. Pain [ Time Frame: four weeks ]
    Changes in pain levels, pain symptoms, pain relief, physical function, pain interference, and pain intensity and pain quality determined using the Brief Pain Inventory

  6. Pain [ Time Frame: Four weeks ]
    Changes in physical function, pain interference, and pain intensity the PROMIS-43 Profile subscales

  7. Patient Satisfaction PSS [ Time Frame: four weeks ]
    Patient satisfaction and impression of change determined using the PSS

  8. Patient Satisfaction PGIC [ Time Frame: four weeks ]
    Patient satisfaction and impression of change determined using the PGIC

  9. Pain medication usage [ Time Frame: four weeks ]
    Changes in the use of pain medications determined using the case report form

  10. hs-CRP [ Time Frame: four weeks ]
    Changes in inflammatory biomarkers assessed by high-sensitivity C-reactive protein (hs-CRP)

  11. ESR [ Time Frame: four weeks ]
    Changes in inflammatory biomarkers assessed by erythrocyte sedimentation rate (ESR)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20-70
  • Body mass index 19 kg/m2 - 40 kg/m2
  • Have had chronic pain lasting 3 months or longer
  • Have moderate to severe pain as define by an average level of pain score of greater than or equal to a 4 on the PROMIS-43 Profile - Pain Intensity subscale
  • Willing to have blood drawn three times
  • Maintained stable medications, dietary supplements and therapies for pain for at least 30 days and willing to continue the same therapies and not add new therapies for the duration of the study unless medically advised to do so
  • Able to follow study protocol and attend visits at the clinical practices associated with Clinical Investigator
  • Able to speak, read and understand English

Exclusion Criteria:

  • Initiation of or changes in use of fish oil supplements, krill oil supplements, omega 3 supplements, or omega 3-based drugs (Lovaza®, etc.) within the past 3 months
  • Initiation of new pain medications and non-steroidal anti-inflammatory drugs NSAIDS within the past month such as [aspirin, ibuprofen (Advil®, Motrin®, Nuprin®), acetaminophen (Tylenol®), naproxen (Aleve®, Naprosyn®), codeine (Vicodin®), morphine (Dilaudid®), oxycodone (OxyContin®, Percocet®) fentanyl (Duragesic®) and COX-2 inhibitors, Celebrex®)
  • Currently taking:

    • Medication to reduce the tendency to form blood clots such as [warfarin, jantoven (Coumadin®); dabigatran (Pradaxa®); rivaroxaban, (Xarelto®); apixaban (Eliquis®)]
    • Statin use for cholesterol reduction such as [atorvastatin (Lipitor®), fluvastatin (Lescol®), lovastatin (Mevacor®, Altocor®), pitavastatin (Livalo®), pravastatin (Pravachol®), rosuvastatin (Crestor®) or simvastatin (Zocor®)] (not including Red Yeast Rice if also supplementing with CoQ10)
    • Corticosteroids such as [prednisone, dexamethasone, prednisolone (Orapred®, Prelone®, Pediapred®), methylprednisolone (Medrol®)] (not including topical corticosteroids for dermatological conditions or nasally inhaled for asthma, rhinitis or sinusitis)
    • Daily aspirin >325 mg per day (not including low dose aspirin therapy of 81 mg - 325 mg per day)
  • Other medications and supplements to be evaluated by the investigators on a case-by-case basis
  • Steroid injections, Prolotherapy, or other injections into a ligament, tendon, joint or muscle during the past month or initiation or continuation of therapy injections during the course of the study.
  • Present or past history of any of the following:

    • Inflammatory disease (e.g. rheumatoid arthritis, autoimmune disease, Crohn's disease, diverticulitis, viral hepatitis, ulcerative colitis, systemic lupus, Parkinson's disease, Alzheimer's, ankylosing spondylitis)
    • Blood clot disorder (e.g., phlebitis)
    • Diabetes (self-report; includes Type I and Type II Diabetes but does not include a history of Gestational Diabetes during pregnancy)
    • Cancer within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix)
    • Cardiovascular disease within the last year, including but not limited to: myocardial infarction, stroke, congestive heart failure (CHF)
    • Kidney failure or liver failure
  • Current active pelvic inflammatory disease, urinary tract infection or a kidney infection
  • Women who are lactating, pregnant or planning pregnancy within the next six months
  • Difficulty or aversion to swallowing soft gels, capsules, tablets or pills
  • Known intolerance or allergy to fish oils
  • Upon administering the NCNM Adverse Event Monitoring form at screening, a sign or symptom of Grade 3 (severe or medically significant but not immediately life-threatening) or higher is reported
  • Currently participating in another research study or participated in another study within the last month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683850


Locations
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United States, Oregon
National University of Natural Medicine
Portland, Oregon, United States, 97201
Sponsors and Collaborators
National University of Natural Medicine
Metagenics, Inc.
Investigators
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Principal Investigator: Ryan Bradley, ND, MPH National University of Natural Medicine
Publications:

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Responsible Party: Ryan Bradley, Assistant Director of Research, National University of Natural Medicine
ClinicalTrials.gov Identifier: NCT02683850    
Other Study ID Numbers: 091515-B
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations