Clinical trial: Investigating the Effect of Deep Sea Krill Oil Supplementation in Osteoarthritis of the Knee (NCT03483090)

Eligibility criteria:
Inclusion Criteria:

          1. Male or Female aged 40 - 65 years, inclusive

          2. Clinical Diagnosis of OA of the index knee according to the ACR Criteria for the
             classification of Idiopathic OA of the Knee

          3. Kellgren-Lawrence (KL) grade 1-3 OA, evidenced by Knee X-ray performed during the
             screening period

          4. Experiencing pain of the index knee on at least 4 days per week for the last 3 months
             (based on self-report)

          5. Pain of the index knee between 4 and 8 cm (inclusive) as self-assessed on a visual
             analogue scale (VAS) over the 7 days prior to Day 1

          6. Body mass index (BMI) >18.5 kg/m2 and <35 kg/m2 on Day 1

          7. Willingness to abstain from use of restricted medications.

          8. Habitual intake of long chain (LC) omega-3 polyunsaturated fatty acids (PUFA) (from
             food and supplements) <500mg/day as assessed using the Australian PUFA food frequency
             questionnaire (FFQ) during the screening period and willingness to maintain a low
             intake throughout the study. Higher intakes of LC omega-3 PUFA will require a 3 month
             washout period.

          9. Willing to provide written Informed Consent.

        Exclusion Criteria:

          1. Severe radiographic knee OA in any knee defined as Kellgren-Lawrence (KL) score >3
             based on X-ray (weight bearing) performed during the screening period.

          2. Ipsilateral hip OA such that it would compromise assessment of knee pain.

          3. Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic
             conditions which could interfere with the evaluation of the index knee.

          4. History of Reiter's syndrome, rheumatoid arthritis (RA), psoriatic arthritis,
             ankylosing spondylitis, arthritis associated with inflammatory bowel disease,
             sarcoidosis or amyloidosis or any other forms of inflammatory arthritis (e.g. gout,
             pseudogout). Gout is excluded unless the participant is on preventative treatment and
             has not had an attack in the last 12 months.

          5. History or clinical signs and symptoms of infection in the index joint in the last 5
             years.

          6. Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low
             back pain and hip pain that is referred to the knee that could cause
             misclassification).

          7. Pain in any other area of the lower extremities or back that is equal to or greater
             than the index knee pain (based on self-report).

          8. Arthroscopy or open knee surgery in the index knee in the previous 12 months or
             planned for the duration of the study period.

          9. Intraarticular (IA) or Intramuscular (IM) corticosteroid (investigational or marketed)
             in any joint within 3 months of Screening or Oral corticosteroids (investigational or
             marketed) within 1 month of Screening.

         10. IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of
             Screening

         11. Any other IA intervention or therapy within 3 months of Screening .

         12. Regular use of opioids/opiates within 4 weeks of Day 1 equivalent to >30mg codeine per
             day, for 5 days or more, unless participant agrees to a washout period of at least 4
             weeks prior to Day 1.

         13. High dose NSAIDs within the last month, defined as at the maximum dose recommended for
             the symptomatic treatment of arthritis pain (e.g., diclofenac ≥150 mg/day, aceclofenac
             ≥100 mg/day, meloxicam ≥15 mg/day, naproxen ≥1,000 mg/day, piroxicam ≥20 mg/day, and
             ibuprofen >2,400 mg/day), unless participant agrees to a washout period of at least 4
             weeks prior to Day 1.

         14. Bleeding disorders, currently taking anticoagulants or has received anticoagulants
             within 28 days of Day 1, with the exception of low dose aspirin up to150mg daily.

         15. Regular use of and not prepared to abstain from glucosamine, fish oil, curcumin and
             other complementary medicines/supplements, that may affect the study results. A
             washout period of minimum of 4 weeks will apply prior to Day 1, except in the case of
             fish oil, where 3 month washout will apply.

         16. Positive urine dipstick pregnancy test at screening or Day 1, currently pregnant
             and/or breastfeeding.

         17. Women of child bearing potential (WOCBP) who:

               1. Are not currently using effective methods of contraception and

               2. have not been using effective methods of contraception for 14 days prior to Day 1
                  and

               3. are not willing to use effective methods of contraception throughout the study

         18. History of or known presence of alcohol abuse or illicit drug use, any surgical
             history, clinically significant conditions (i.e renal or urological disease, cardiac
             disease, liver disease, gastrointestinal disease or any other significant disease) or
             organ dysfunction that in the opinion of the investigator may affect the participant's
             ability to participate in the study or the study results.

         19. Currently hospitalised or any planned hospitalisations during the study or up to 1
             month following the last dose of study product that may affect the participants
             ability to comply with the study in the opinion of the medical investigator.

         20. Received an investigational drug within 3 months of Day 1 that in the opinion of the
             investigator may affect the applicant's ability to participate in the study or the
             study results.

         21. Known or suspected allergies to the investigational products

         22. History of an adverse reaction or known hypersensitivity to seafood or shellfish.

         23. Hypertension (blood pressure ≥140/90 mmHg at screening. (Participants with an elevated
             BP at screening may be included if they are able to provide a treating doctor letter
             stating either that they do not have hypertension or that their hypertension has been
             well controlled for at least 4 weeks).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 1