Astaxanthin for Management of Inflammation in Knee Osteoarthritis

NCT05138549 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: Pro00113612
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Over 30 million Americans are currently affected by osteoarthritis (OA), with prevalence expected to increase 40% by 2025 as a result of the aging population and obesity epidemic. Specifically, symptomatic knee OA is a leading cause of disability. Although originally classified as non-inflammatory arthritis, recent studies suggest that a relationship exists between joint inflammation and OA. Specifically, the complex interaction between sites of local tissue damage and immune cells leads to a state of chronic joint inflammation which may play a key role in disease pathogenesis. The evidence suggesting a role of inflammation in disease progression makes anti-inflammatory agents ideal candidates for symptom management. Astaxanthin, a keto-carotenoid present in many aquatic animals, including salmon, shrimp, and lobster, is an FDA-approved nutraceutical that has powerful antioxidant and anti-inflammatory properties coupled with remarkable safety and tolerability. This prospective, blinded, randomized, placebo-controlled pilot study will evaluate the effect of astaxanthin in reducing inflammation, controlling pain, and improving physical function in patients with advanced knee osteoarthritis awaiting total joint replacement surgery. Levels of pro- and anti-inflammatory cytokines and chemokines will be measured following the completion of a daily oral regimen of astaxanthin vs. placebo. Additionally, patient-reported outcome measurements assessing physical function and pain interference will be obtained prior to and following completion of treatment allowing for a comparison between treatment groups. Study outcomes will provide evidence to support astaxanthin supplementation as a cost-effective, added strategy for symptom management in patients with advanced osteoarthritis.

Conditions

Osteoarthritis, Knee; Osteoarthritis Knees Both; Joint Inflammation

Outcome Measures

Primary Outcomes (1)

• Effect of Astaxanthin on Inflammatory Synovial Markers in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.

  We will address this by conducting a prospective, double-blinded, randomized, placebo-controlled trial in which 160 patients who have been diagnosed with advanced osteoarthritis of the knee and are scheduled to undergo a total knee replacement will randomly receive a 6-week oral daily course of either astaxanthin (12 mg) or placebo prior to surgery. Levels of pro- and anti-inflammatory cytokines and chemokines within the intra-articular synovial fluid at the time of surgery will be quantified using a bioplex 23-cytokine and chemokine assay kit in post-treatment synovial fluid samples from patients receiving either astaxanthin or placebo.

  6 Weeks

Secondary Outcomes (2)

• Effect of Astaxanthin on PROMIS Physical Function Scores in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.

  6 Weeks

• Effect of Astaxanthin on PROMIS Pain Interference Scores in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.

  6 weeks

Study Arms (2)

Control: Placebo Group

PLACEBO COMPARATOR

Patients will receive a 6 week daily oral supply of placebo, identical in appearance to the astaxanthin supplement.

Other: Placebo

Experimental: Astaxanthin Supplementation Group

ACTIVE COMPARATOR

Patients will receive a 6 week daily oral supply of 12 mg astaxanthin supplement.

Drug: Astaxanthin

Interventions

Astaxanthin DRUG

12 mg oral astaxanthin supplement

Also known as: Astaxanthine, Astaxantina, Dihydroxy-3,3' dioxo-4,4' bêta-carotène

Experimental: Astaxanthin Supplementation Group

Placebo OTHER

Oral placebo identical to astaxanthin supplement

Control: Placebo Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Radiographic evidence of advanced knee osteoarthritis
• Knee pain
• Scheduled to undergo a total knee replacement

You may not qualify if:

• \< 18 years of age
• Unable to provide written consent
• Known allergy to fish or astaxanthin
• Pregnant and/or breastfeeding
• Received a corticosteroid injection within 3 months of initiating treatment with astaxanthin or placebo
• Currently taking immunosuppressants
• Patients with known autoimmune etiology for arthritis (e.g. Rheumatoid or Psoriatic arthritis)

Sponsors & Collaborators

• Prisma Health-Midlands: lead

Study Sites (1)

Prisma Health

Columbia, South Carolina, 29203, United States

Location

Related Publications (8)

• Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

  PMID: 20699159 BACKGROUND

• Sun K, Luo J, Jing X, Guo J, Yao X, Hao X, Ye Y, Liang S, Lin J, Wang G, Guo F. Astaxanthin protects against osteoarthritis via Nrf2: a guardian of cartilage homeostasis. Aging (Albany NY). 2019 Nov 26;11(22):10513-10531. doi: 10.18632/aging.102474. Epub 2019 Nov 26.

  PMID: 31772142 BACKGROUND

• Farr Ii J, Miller LE, Block JE. Quality of life in patients with knee osteoarthritis: a commentary on nonsurgical and surgical treatments. Open Orthop J. 2013 Nov 13;7:619-23. doi: 10.2174/1874325001307010619. eCollection 2013.

  PMID: 24285987 BACKGROUND

• Vitaloni M, Botto-van Bemden A, Sciortino Contreras RM, Scotton D, Bibas M, Quintero M, Monfort J, Carne X, de Abajo F, Oswald E, Cabot MR, Matucci M, du Souich P, Moller I, Eakin G, Verges J. Global management of patients with knee osteoarthritis begins with quality of life assessment: a systematic review. BMC Musculoskelet Disord. 2019 Oct 27;20(1):493. doi: 10.1186/s12891-019-2895-3.

  PMID: 31656197 BACKGROUND

• Sokolove J, Lepus CM. Role of inflammation in the pathogenesis of osteoarthritis: latest findings and interpretations. Ther Adv Musculoskelet Dis. 2013 Apr;5(2):77-94. doi: 10.1177/1759720X12467868.

  PMID: 23641259 BACKGROUND

• Scanzello CR, Goldring SR. The role of synovitis in osteoarthritis pathogenesis. Bone. 2012 Aug;51(2):249-57. doi: 10.1016/j.bone.2012.02.012. Epub 2012 Feb 22.

  PMID: 22387238 BACKGROUND

• Higuera-Ciapara I, Felix-Valenzuela L, Goycoolea FM. Astaxanthin: a review of its chemistry and applications. Crit Rev Food Sci Nutr. 2006;46(2):185-96. doi: 10.1080/10408690590957188.

  PMID: 16431409 BACKGROUND

• Park JS, Chyun JH, Kim YK, Line LL, Chew BP. Astaxanthin decreased oxidative stress and inflammation and enhanced immune response in humans. Nutr Metab (Lond). 2010 Mar 5;7:18. doi: 10.1186/1743-7075-7-18.

  PMID: 20205737 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Harley T. Davis
• Organization: Prisma Health

pamela.davis2@prismahealth.org

8032969533

Study Officials

• Daniel Del Gaizo, MD

  Prisma Health-Midlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, care providers, and investigators will not know which arm patients have been assigned to or if they receive placebo or astaxanthin.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to receive 6 weeks of oral supplementation of either placebo or 12 mg astaxanthin prior to total knee replacement surgery.

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 1, 2021
• Study Start: September 2, 2022
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)