Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators
NCT ID: NCT03664466
Last Updated: 2022-04-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2021-04-29
Study Completion Date
2022-01-25
Brief Summary
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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).
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Detailed Description
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Conditions
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Osteoarthritis, Knee
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
double-blind
Study Groups
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Astaxanthin
Astaxanthin 12mg twice daily by mouth
Group Type
EXPERIMENTAL
astaxanthin
Intervention Type
DIETARY_SUPPLEMENT
astaxanthin capsules 12 mg twice daily
Placebo
Placebo twice daily by mouth
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
placebo capsules twice daily
Interventions
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astaxanthin
astaxanthin capsules 12 mg twice daily
Intervention Type
DIETARY_SUPPLEMENT
Placebo
placebo capsules twice daily
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Saint Luke's Health System
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jennifer Elliott, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Hospital, Kansas City, Missouri
Locations
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Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Site Status
Countries
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United States
References
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Other Identifiers
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AXE OA PAIN
Identifier Type: -
Identifier Source: org_study_id
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