Astaxanthin for Management of Inflammation in Knee Osteoarthritis

NCT ID: NCT05138549

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2023-11-14

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.

Detailed Description

Osteoarthritis (OA) is a common degenerative joint disorder that affects a significant portion of the population. Over 30 million Americans are currently affected by the disease, 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, occurring in 10% of men and 13% of women over the age of 60. Patients with symptomatic OA often experience pain, swelling, and stiffness of the knee resulting in a decrease in physical mobility which can have a drastic impact on quality of life. In addition to the significant impact on affected individuals, OA is associated with an enormous economic burden estimated at $136.8 billion annually in the US, surpassing costs of tobacco-related health effects, diabetes, and cancer.

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 is a keto-carotenoid present in many aquatic animals, including salmon, shrimp, and lobster, that has demonstrated heightened antioxidant activity and the ability to suppress inflammation. Early evidence suggests that astaxanthin may protect against osteoarthritis in vivo, illustrating its potential as a therapeutic supplement for patients with OA. However, studies illustrating these effects in humans have yet to be conducted.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control: Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Oral placebo identical to astaxanthin supplement

Experimental: Astaxanthin Supplementation Group

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

Group Type: ACTIVE_COMPARATOR

Astaxanthin

Intervention Type: DRUG

12 mg oral astaxanthin supplement

Interventions

Astaxanthin

12 mg oral astaxanthin supplement

Intervention Type: DRUG

Placebo

Oral placebo identical to astaxanthin supplement

Intervention Type: OTHER

Other Intervention Names

Astaxanthine; Astaxantina; Dihydroxy-3,3' dioxo-4,4' bêta-carotène

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• < 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Midlands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Del Gaizo, MD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Midlands

Locations

Prisma Health

Columbia, South Carolina, United States

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 20699159 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31772142 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24285987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31656197 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23641259 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22387238 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16431409 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20205737 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Pro00113612

Identifier Type: -

Identifier Source: org_study_id