Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators

NCT03664466 | Withdrawn

• 1 other identifier: AXE OA PAIN
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Change in PROMIS Numeric Rating Pain Scale

  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 Outcomes (6)

• Change in PROMIS Pain interference score

  20 weeks

• Change in PROMIS Physical function score

  20 weeks

• Change in Erythrocyte Sedimentation Rate

  20 weeks

• Change in C-reactive protein levels

  20 weeks

• Change in Interleukin-6 levels

  20 weeks

Study Arms (2)

Astaxanthin

EXPERIMENTAL

Astaxanthin 12mg twice daily by mouth

Dietary Supplement: astaxanthin

Placebo

PLACEBO COMPARATOR

Placebo twice daily by mouth

Other: Placebo

Interventions

astaxanthin DIETARY_SUPPLEMENT

astaxanthin capsules 12 mg twice daily

Astaxanthin

Placebo OTHER

placebo capsules twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Luke's Health System: lead

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jennifer Elliott, MD

  St. Luke's Hospital, Kansas City, Missouri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: September 10, 2018
• Study Start: April 29, 2021
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)