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Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03664466
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Saint Luke's Health System
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jennifer Elliott, MD
Principal Investigator Affiliation Saint Luke's Hospital of Kansas City
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee
Arms & Interventions

Arms

Experimental: Astaxanthin

Astaxanthin 12mg twice daily by mouth

Placebo Comparator: Placebo

Placebo twice daily by mouth

Interventions

Dietary Supplement: - astaxanthin

astaxanthin capsules 12 mg twice daily

Other: - Placebo

placebo capsules twice daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Saint Luke's Hospital of Kansas City, Kansas City, Missouri

Status

Recruiting

Address

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

Site Contact

Jennifer Elliott, MD

[email protected]

816-932-2831

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