Osteoarthritis Knee Pain, Osteoarthritis (OA) of the Knee
Conditions
Brief 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.
Interventions
DRUGKrill oil
Antarctic krill oil was used for intervention in the experimental group.
DIETARY_SUPPLEMENTOlive Oil
Olive oil was used for intervention in the placebo group.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 45-75 years； * Clinically diagnosed with knee osteoarthritis per the Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 edition) issued by the Chinese Medical Association, with Kellgren-Lawrence grade 1-3； * Knee pain Visual Analog Scale (VAS) score between 4.0 and 8.0； * Ability to comprehend and complete VAS and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessments； * Willingness and ability to undergo knee MRI examinations.
Exclusion criteria
* Ipsilateral hip osteoarthritis; * Diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis, sarcoidosis, amyloidosis, or any other inflammatory arthritis (e.g., gout, pseudogout); * Chronic pain syndromes, fibromyalgia, or comorbidities that may confound knee pain assessment; * Pain intensity in the lower extremities or back equal to or greater than knee pain; * Arthroscopic or open knee surgery within the preceding 12 months or planned during the study period; * Oral, intra-articular, or intramuscular corticosteroid use within 6 months prior to screening or during the study; * Intra-articular hyaluronic acid injection within 6 months prior to screening or during the study; * High-dose NSAID use (≥ maximum recommended daily dose for osteoarthritis pain relief) within 1 month prior to screening, including but not limited to: Diclofenac ≥150 mg/day; Aceclofenac ≥100 mg/day; Meloxicam ≥15 mg/day; Naproxen ≥1,000 mg/day; Piroxicam ≥20 mg/day; Ibuprofen \>2,400 mg/day (Exempt if a ≥4-week washout period is completed prior to Day 1); * Bleeding disorders or anticoagulant use within 1 month (except low-dose aspirin ≤150 mg/day); * Regular use of glucosamine, fish oil, or other supplements unless a ≥4-week washout period (≥3 months for fish oil) is completed prior to Day 1; * Hypersensitivity to trial medications or seafood; * Administration of any medication within 6 months prior to Day 1 that may interfere with study outcomes, as judged by investigators; * Pregnancy (positive urine test at screening or Day 1), lactation, or inadequate contraception; * History of alcoholism, substance abuse, major systemic diseases (e.g., renal, cardiac, hepatic, or gastrointestinal disorders), or conditions deemed by investigators to compromise study participation or data integrity; * Uncontrolled hypertension (screening blood pressure ≥140/90 mmHg) unless confirmed as non-hypertensive or well-controlled by a specialist; * Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Pain Scale | Baseline and week 24 after treatment initiation | Joint pain severity was assessed using the Visual Analogue Scale (VAS). |
| Adverse Reactions | Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation | Safety assessment of the treatment requires written documentation of adverse reactions, including their time of occurrence, frequency, and severity grading. |
| Serious Adverse Reactions | Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation | Safety assessment of the treatment requires written documentation of serious adverse reactions, including their time of occurrence, frequency, and severity grading. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Joint Effusion | Baseline, weeks 12 and 24 after treatment initiation | To measure the volume of joint effusion, magnetic resonance imaging is used to scan the joint area and calculate the amount of effusion. |
| WOMAC Pain Subscale | Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation | Joint pain severity was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. |
| VAS Pain Score Change from Baseline | Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation | To measure the degree of joint pain, the Pain Visual Analog Scale (VAS) is used for evaluation. The baseline change value of the Pain Visual Analog Scale is obtained by subtracting the initial measurement score at week 0 from the obtained score. |
| WOMAC Stiffness Subscale | Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation | Degree of joint stiffness was evaluated with the WOMAC Stiffness Subscale. |
| WOMAC Physical Function Subscale | Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation | Joint functional ability was measured by the WOMAC Physical Function Subscale. |
Contacts
Primary ContactYuankai Zhang Qilu Hospital of Shandong University
Outcome results
None listed