Influence of an Omega-3 SPM Supplement on Quality of Life
Completed · Early Phase 1
Conditions studied: Chronic Pain
In brief
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.
Key facts
- Study ID
- NCT02683850
- Run by
- National University of Natural Medicine
- People needed
- 44
- Starts
- 2016-01-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2016-09-02
Who can join
Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- National University of Natural Medicine — Portland, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.