Antarctic Krill Oil for Knee Osteoarthritis Pain

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Mar 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Antarctic Krill Oil (AKO) as a dietary supplement for people experiencing pain from knee osteoarthritis (OA). The main goals are to see if taking AKO can help reduce daily pain and to check for any side effects that participants might experience. The researchers will conduct a randomized study where some participants will get AKO and others will receive a placebo (a harmless pill that looks the same but has no active ingredients). They will monitor changes in pain levels, how well participants can perform daily activities, and overall safety.

To be eligible for this study, participants should be between 45 and 75 years old and have a diagnosis of knee osteoarthritis with a specific level of pain. They should also be able to complete assessments of their pain and be willing to undergo knee MRI scans. However, certain conditions, such as having other types of arthritis or recent knee surgeries, would make someone ineligible. If you decide to participate, you can expect to be part of a study that aims to improve treatment options for knee pain while helping researchers learn more about the safety and effectiveness of AKO.

Gender

ALL

Eligibility criteria

• 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.