NCT02683850

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National University of Natural Medicine · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-02-17
• Last updated: 2016-09-02

Locations

1 site across 1 country: United States