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NCT05138549 · ClinicalTrials.gov registry record · Phase 2
Astaxanthin for Management of Inflammation in Knee Osteoarthritis
A Phase 2 study, sponsored by Prisma Health-Midlands.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT05138549 is a Phase 2 study that was terminated before completion, run by Prisma Health-Midlands. The registered enrollment target is 16 participants.
The verdict
NCT05138549, a Phase 2 study, was terminated before completion, sponsored by Prisma Health-Midlands.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG Astaxanthin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-09-02 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05138549
The ClinicalTrials.gov registry entry for NCT05138549 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prisma Health-Midlands, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05138549 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05138549 about?
NCT05138549 is a clinical study titled "Astaxanthin for Management of Inflammation in Knee Osteoarthritis". 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 a...
What is the current status of trial NCT05138549?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2022-09-02. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT05138549?
The interventions under investigation include: Placebo (OTHER), Astaxanthin (DRUG).
Who is sponsoring clinical trial NCT05138549?
This trial is sponsored by Prisma Health-Midlands, which has 7 total clinical trials registered on ClinicalTrials.gov.
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