Osteoarthritis (OA) of the KneePhase 2NCT06880926
Antarctic Krill Oil for Knee Osteoarthritis Pain
A Phase 2 study testing Krill oil and Olive Oil in people with Osteoarthritis (OA) of the Knee and Osteoarthritis Knee Pain, run by Qilu Hospital of Shandong University.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, Osteoarthritis Knee Pain
- What is being tested?
- Krill oil and Olive Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Parallel-Controlled, Multicenter Clinical Trial of Antarctic Krill Oil in the Management of Knee Osteoarthritis Pain
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.
Read the 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.
- Being tested
- Krill oil, Olive Oil
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oilDrug
Antarctic krill oil was used for intervention in the experimental group.
Olive OilDietary supplement
Olive oil was used for intervention in the placebo group.
| Study group | Role | What they receive |
|---|---|---|
| Olive oil | Placebo comparator | Oral administration of olive oil : 2 grams per dose, once daily, for a duration of 24 weeks. Receives: Dietary Supplement: Olive Oil |
| Antarctic krill oil | Experimental | Oral administration of antarctic krill oil : 2 grams per dose, once daily, for a duration of 24 weeks. Receives: Drug: Krill oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Pain Scale
Joint pain severity was assessed using the Visual Analogue Scale (VAS).
Measured: Baseline and week 24 after treatment initiation
Adverse Reactions
Safety assessment of the treatment requires written documentation of adverse reactions, including their time of occurrence, frequency, and severity grading.
Measured: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
Serious Adverse Reactions
Safety assessment of the treatment requires written documentation of serious adverse reactions, including their time of occurrence, frequency, and severity grading.
Measured: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
Secondary outcomes (5)
WOMAC Pain Subscale
Joint pain severity was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.
Measured: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
WOMAC Stiffness Subscale
Degree of joint stiffness was evaluated with the WOMAC Stiffness Subscale.
Measured: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
WOMAC Physical Function Subscale
Joint functional ability was measured by the WOMAC Physical Function Subscale.
Measured: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
Volume of Joint Effusion
To measure the volume of joint effusion, magnetic resonance imaging is used to scan the joint area and calculate the amount of effusion.
Measured: Baseline, weeks 12 and 24 after treatment initiation
VAS Pain Score Change from Baseline
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.
Measured: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880926
- Sponsor's protocol ID
- KYLL-202412-004-1
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Controlled, Multicenter Clinical Trial of Antarctic Krill Oil in the Management of Knee Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT06880926
- Acronym / sponsor ID
- KYLL-202412-004-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olive oil | Placebo comparator | Dietary Supplement: Olive OilOral administration of olive oil : 2 grams per dose, once daily, for a duration of 24 weeks. |
| Antarctic krill oil | Experimental | Drug: Krill oilOral administration of antarctic krill oil : 2 grams per dose, once daily, for a duration of 24 weeks. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill oilAntarctic krill oil was used for intervention in the experimental group. | Drug | Antarctic krill oil |
| Olive OilOlive oil was used for intervention in the placebo group. | Dietary supplement | Olive oil |
Primary outcome
Visual Analogue Pain Scale
Time frame: Baseline and week 24 after treatment initiation
Joint pain severity was assessed using the Visual Analogue Scale (VAS).
Adverse Reactions
Time frame: 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
Time frame: 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.
5 secondary outcomes
WOMAC Pain Subscale
Time frame: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
WOMAC Stiffness Subscale
Time frame: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
WOMAC Physical Function Subscale
Time frame: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
Volume of Joint Effusion
Time frame: Baseline, weeks 12 and 24 after treatment initiation
VAS Pain Score Change from Baseline
Time frame: Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
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A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)
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Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Krill oil and Olive Oil in people with Osteoarthritis (OA) of the Knee and Osteoarthritis Knee Pain, run by Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuankai Zhang Qilu Hospital of Shandong University (+86 18560082587, drzhangyk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Pain Scale (time frame: Baseline and week 24 after treatment initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.