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Terminated Phase 2Phase 3 Interventional Results available

Astaxanthin for Management of Inflammation in Knee Osteoarthritis

ClinicalTrials.gov ID: NCT05138549

Public ClinicalTrials.gov record NCT05138549. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 1:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Effect of Astaxanthin for Pain, Function, and Inflammation in Patients With Advanced Osteoarthritis Awaiting Total Knee Replacement Surgery

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05138549
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Prisma Health-Midlands
Other
Enrollment
16 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 1, 2022
Primary completion
Nov 13, 2023
Completion
Nov 13, 2023
Last update posted
May 19, 2025

2022 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Prisma Health Columbia South Carolina 29203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05138549, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 19, 2025 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05138549 live on ClinicalTrials.gov.

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