A randomised trial of krill oil for osteoarthritis of the knee

Phase 4

Recruiting

• Conditions: Musculoskeletal - Osteoarthritis; osteoarthritis

• Registration Number: ACTRN12616000726459
• Lead Sponsor: niversity of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1.Aged over 40 years old.
2.Men and women with significant knee pain on most days (defined as a VAS >40mm).
3.Knee effusion–synovitis on MRI: In TASOAC study the proportion of participants who had effusion–synovitis on MRI was high (67%), suggesting that localised knee inflammation is common and that MRI is an appropriate screening tool.
4.Meet American College of Rheumatology (ACR) clinical criteria for knee OA confirmed by a rheumatologist.

Exclusion Criteria

1.Inability to have an MRI (claustrophobia, metal in eyes or selected knee, pacemakers).
2.Severe knee OA (joint space narrowing (JSN) on X-ray of Grade 3 using the Osteoarthritis Research Society International (OARSI) atlas).
3.Use of anticoagulants, high dose aspirin or non-steroidal anti–inflammatory drugs (NSAIDs), as krill oil is contra–indicated in such people.
4.Unwillingness to stop taking krill oil and fish oil medications 30 days prior to the trial and during the trial.
5.Other forms of inflammatory arthritis (especially rheumatoid arthritis and gout).
6.Seafood allergy.
7.Significant knee injury within the last 6 months.
8.Arthroscopy or open surgery in the index knee in the last 12 months, or planned.
9.Injections of corticosteroids (last 3 months) or hyaluronic acid (last 6 months) in the index knee.
10.Pregnancy or breastfeeding.
11.Use of any investigational drug(s) and/or devices within 30 days prior to randomisation
12.Presence of any serious medical illness that may preclude 24 week follow up.
13.Inability to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in knee pain (assessed by 100mm VAS) over 24 weeks in patients with clinical knee OA, significant knee pain and effusions.[Mixed model accounting for overall pain at baseline, 4, 12, 16, 20 and 24 weeks];Change in effusion size from baseline to 24 weeks measured using MRI quantitative measurements in patients with symptomatic OA of the knee and knee effusion.<br>[Baseline and 24 weeks]