Last updated on November 2018

Investigating the Effect of Deep Sea Krill Oil Supplementation in Osteoarthritis of the Knee

Brief description of study

To evaluate the effectiveness of 4 g Swisse High Strength Deep Sea Krill Oil (Superba BOOST) daily on pain reduction in adults with mild to moderate osteoarthritis of the knee compared to placebo over a 6 month period.

This is a multicentre, randomised, double-blind, placebo-controlled parallel-arm study.

Applicants will be eligible to participate if they have mild to moderate OA of the knee. Diagnosis of OA of the knee will be made according to clinical diagnosis, using the American College of Rheumatology (ACR) Criteria for the classification of Idiopathic OA of the Knee and the Kellgren-Lawrence grading scale. In addition, eligible applicants will have been experiencing knee pain on at least 4 days per week, for at least 3 months and they will report knee pain between 4 and 8 cm (inclusive) on a visual analogue scale (VAS) for the 7 days prior to Day 1 of the trial (Baseline). Severity of OA of the knee will be assessed based on X-ray performed at the Screening Visit using the Kellgren-Lawrence (KL) radiographic criteria, and participants with severe radiographic knee OA (KL joint space narrowing (JSN) above grade 3) will be excluded.

Applicants will attend a screening visit following pre-screening assessments to assess their general health and eligibility for inclusion into the study.

On Day 1 eligible participants will be randomly allocated to receive one of two study treatments. Participants will take the assigned treatments daily for six months.

Participants will return to the clinic at 3 months and 6 months for study assessments. Participants will complete an online survey at 1, 2, 4 and 5 months to assess protocol compliance, adverse events and use of concomitant medications. Any queries from the survey will be followed up by phone call.

A final participant online survey and phone call (if needed) will be conducted 28 days after the 6 month visit for a final safety assessment.

Clinical Study Identifier: NCT03483090

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Emeritus Research

Camberwell, Australia
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