Clinical trial NCT03664466: Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators
Official title: Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Symptoms of knee pain
* Radiographic evidence of mild to moderate arthritis
* Able to provide written consent on their own behalf

Exclusion Criteria:

* Pregnancy
* Current tobacco use
* Current substance abuse (alcohol or drug)
* Presence of significant cardiovascular, pulmonary, hepatic, or renal disease
* Prior history of knee trauma or surgery
* Gout or pseudogout
* Significant depression or anxiety scores on PHQ-9 and GAD-7, or pre-existing diagnosis of a significant mental health disorder
* Presence of other chronic pain syndromes such as chronic low back or neck pain, fibromyalgia, or complex regional pain syndrome
* Presence of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease
* Symptomatic involvement of multiple other joints with osteoarthritis
* Known allergy to fish or astaxanthin
* BMI greater than 35
* Participation in another clinical trial

Primary outcomes:
measure: Change in PROMIS Numeric Rating Pain Scale
timeFrame: 20 weeks
Secondary outcomes:
measure: Change in PROMIS Pain interference score
timeFrame: 20 weeks
measure: Change in PROMIS Physical function score
timeFrame: 20 weeks
measure: Change in Erythrocyte Sedimentation Rate
timeFrame: 20 weeks
measure: Change in C-reactive protein levels
timeFrame: 20 weeks
measure: Change in Interleukin-6 levels
timeFrame: 20 weeks
measure: Change in Cartilage Oligomeric Matrix Protein levels
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
Study officials:
affiliation: St. Luke's Hospital, Kansas City, Missouri
name: Jennifer Elliott, MD
role: PRINCIPAL_INVESTIGATOR
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