An interventional study of astaxanthin and Placebo in Osteoarthritis, Knee, sponsored by Saint Luke's Health System. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by Saint Luke's Health System · Not applicable, Interventional, and Treatment
This study is intended to assess the effects of astaxanthin use on pain, physical function, and inflammation as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS) scores and levels of inflammatory biomarkers in subjects taking astaxanthin. If improvements in pain, function, and/or markers of inflammation could be demonstrated with the use of astaxanthin, this may suggest the potential for astaxanthin to be used in management of knee osteoarthritis (and possibly other forms of osteoarthritis) with less evident toxicity than seen with the presently available standard therapies (e.g. NSAIDS, opioids).
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
Browse Osteoarthritis studies →Saint Luke's Health System is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Astaxanthin 12mg twice daily by mouth
Dietary Supplement: astaxanthin
Placebo twice daily by mouth
Other: Placebo
astaxanthin capsules 12 mg twice daily
placebo capsules twice daily
Change in PROMIS Numeric Rating Pain Scale
Pain improvement in subjects is the primary outcome measure. The Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity Scale 1a tool will be used. This scale ranges from 0-10, with 0 representing no pain and 10 representing the worst pain imaginable.
Time frame: 20 weeks
Change in PROMIS Pain interference score
Reduction in pain interference is a secondary outcome measure. The Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Interference Short Form 6b will be used as the survey tool for pain interference. This is a set of 6 questions to assess the degree to which pain has interfered with daily activities. There are 5 levels of pain interference from 0 (none at all) to 5 (very much or always). The higher the score, the greater the pain interference.
Time frame: 20 weeks
Change in PROMIS Physical function score
Improvement in physical function is a secondary outcome measure. The PROMIS Physical Function Short Form 6b will be used as the survey tool for physical limitation. There are 5 levels of limitation to physical function from 0 (without any difficulty) to 5 (unable to do). The higher the score, the greater the limitation
Time frame: 20 weeks
Change in Erythrocyte Sedimentation Rate
Change in ESR (mm/hr)
Time frame: 20 weeks
Change in C-reactive protein levels
Change in CRP levels (mg/L)
Time frame: 20 weeks
Change in Interleukin-6 levels
Change in IL-6 levels (pg/mL)
Time frame: 20 weeks
Change in Cartilage Oligomeric Matrix Protein levels
Change in COMP levels (ng/mL)
Time frame: 20 weeks
Plan to share: No
This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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