Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators (AXE OA PAIN)

Saint Luke's Health System

Status

Withdrawn

Conditions

Osteoarthritis, Knee

Treatments

Dietary Supplement: astaxanthin

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03664466

AXE OA PAIN

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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