NCT06880926

Antarctic Krill Oil for Knee Osteoarthritis Pain

A Randomized, Double-Blind, Parallel-Controlled, Multicenter Clinical Trial of Antarctic Krill Oil in the Management of Knee Osteoarthritis Pain

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of Antarctic Krill Oil (AKO) as a dietary supplement in managing pain associated with knee osteoarthritis (OA). The main questions it aims to answer are: ①Does AKO reduce daily pain intensity in participants with moderate knee OA? ②What adverse effects do participants experience when taking AKO? Researchers will conduct a randomized, double-blind study comparing AKO to a placebo (identical appearance without active components) to assess: * Changes in joint pain severity; ②Functional improvement in daily activities; ③Biochemical safety parameters,etc.

Detailed description

Osteoarthritis (OA) is a chronic degenerative disease affecting the entire joint apparatus, characterized by pathological alterations in articular cartilage, subchondral bone, synovium, and joint capsule, clinically manifested by high rates of disability and deformity. With the accelerating aging population in China, the prevalence of OA has risen significantly, garnering substantial academic attention. Current management for early-to-moderate OA predominantly relies on oral non-steroidal anti-inflammatory drugs (NSAIDs), intra-articular hyaluronic acid injections, and glucocorticoids. For advanced cases, total joint arthroplasty remains the definitive intervention, while no disease-modifying therapies have been established to date. Antarctic krill oil, a nutrient-dense marine extract, contains clinically relevant bioactive components including phospholipids, eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA), which are critical mediators of its therapeutic potential. Despite emerging interest, clinical evidence regarding krill oil's efficacy in alleviating OA-related pain and improving joint function remains limited, underscoring the need for further exploration of its role in OA management. This clinical trial aims to evaluate the efficacy and safety of Antarctic krill oil supplementation in reducing pain severity among patients with knee osteoarthritis (KOA), with the ultimate goal of expanding evidence-based therapeutic options for KOA pain management.

Conditions

• Osteoarthritis (OA) of the Knee
• Osteoarthritis Knee Pain

Interventions

Type	Name	Description
DRUG	Krill oil	Antarctic krill oil was used for intervention in the experimental group.
DIETARY_SUPPLEMENT	Olive Oil	Olive oil was used for intervention in the placebo group.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2025-03-18
• Last updated: 2025-03-18