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

April 11, 2022 updated by: Saint Luke's Health System
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Astaxanthin
Astaxanthin 12mg twice daily by mouth
Dietary supplement: astaxanthin
astaxanthin capsules 12 mg twice daily
Placebo Comparator: Placebo
Placebo twice daily by mouth
Other: Placebo
placebo capsules twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PROMIS Numeric Rating Pain Scale
Time Frame: 20 weeks
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.
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PROMIS Pain interference score
Time Frame: 20 weeks
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.
20 weeks
Change in PROMIS Physical function score
Time Frame: 20 weeks
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
20 weeks
Change in Erythrocyte Sedimentation Rate
Time Frame: 20 weeks
Change in ESR (mm/hr)
20 weeks
Change in C-reactive protein levels
Time Frame: 20 weeks
Change in CRP levels (mg/L)
20 weeks
Change in Interleukin-6 levels
Time Frame: 20 weeks
Change in IL-6 levels (pg/mL)
20 weeks
Change in Cartilage Oligomeric Matrix Protein levels
Time Frame: 20 weeks
Change in COMP levels (ng/mL)
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Investigators

  • Principal Investigator: Jennifer Elliott, MD, Saint Luke's Hospital of Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Actual)

January 25, 2022

Study Completion (Actual)

January 25, 2022

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXE OA PAIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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