Antarctic Krill Oil for Knee Osteoarthritis Pain

NCT06880926 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: KYLL-202412-004-1
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis (OA) of the Knee; Osteoarthritis Knee Pain

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Pain Scale

  Joint pain severity was assessed using the Visual Analogue Scale (VAS).

  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.

  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.

  Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation

Secondary Outcomes (5)

• WOMAC Pain Subscale

  Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation

• WOMAC Stiffness Subscale

  Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation

• WOMAC Physical Function Subscale

  Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation

• Volume of Joint Effusion

  Baseline, weeks 12 and 24 after treatment initiation

• VAS Pain Score Change from Baseline

  Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation

Study Arms (2)

Olive oil

PLACEBO COMPARATOR

Oral administration of olive oil : 2 grams per dose, once daily, for a duration of 24 weeks.

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.

Drug: Krill oil

Interventions

Krill oil DRUG

Antarctic krill oil was used for intervention in the experimental group.

Antarctic krill oil

Olive Oil DIETARY_SUPPLEMENT

Olive oil was used for intervention in the placebo group.

Olive oil

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Yuankai Zhang Qilu Hospital of Shandong University

CONTACT

+86 18560082587; drzhangyk@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: April 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03