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

NCT03483090 | Completed Phase 2

• 1 other identifier: SUB-001
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

mild; moderate; krill oil; pain; osteoarthritis; supplement

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Pain subscale (Numeric Rating Scale)

  WOMAC scale is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); Physical Function (17 items): Questionnaire scores on a scale of 0-4, None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The primary outcome related to the Pain subscale and will therefore be scored between 0 and 20.

  from Baseline to 6 months

Secondary Outcomes (12)

• WOMAC B (stiffness subscale) change from Baseline

  from Baseline to 6 months

• WOMAC C (function subscale) change from Baseline

  from Baseline to 6 months

• Serum lipid concentrations (total cholesterol, HDL-C, LDL-C, triglycerides) changes from baseline (efficacy)

  from Baseline to 6 months

• Change in inflammatory markers (IL-6, TNF-α, hsCRP) from Baseline

  from Baseline to 6 months

• Omega 3 index changes from Baseline

  from Baseline to 6 months

Study Arms (2)

Treatment A

EXPERIMENTAL

4000mg Swisse High Strength Deep Sea Krill Oil (Superba BOOST) (4 capsules containing 1000mg each)

Dietary Supplement: Swisse High Strength Deep Sea Krill Oil

Treatment B

PLACEBO COMPARATOR

4 capsules of matching Placebo orally daily (1000mg each of mixed vegetable Oil)

Other: Placebo

Interventions

Swisse High Strength Deep Sea Krill Oil DIETARY_SUPPLEMENT

Krill oil is sourced sustainably from the Southern Ocean and is extracted from the Antarctic Krill, the most abundant marine biomass. Krill oil is a source of omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for the maintenance of good health. Omega-3, EPA and DHA are also found in phospholipid form which are much easier absorbed than triglyceride form of omega-3 which is found in fish oil. Omega-3 supports cardiovascular health, brain health and eye health. Preliminary research suggests krill oil can provide temporary relief from symptoms of mild arthritis, help reduce joint inflammation and increase joint mobility.

Also known as: Superba BOOST

Treatment A

Placebo OTHER

No therapeutic effect

Treatment B

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female aged 40 - 65 years, inclusive
• Clinical Diagnosis of OA of the index knee according to the ACR Criteria for the classification of Idiopathic OA of the Knee
• Kellgren-Lawrence (KL) grade 1-3 OA, evidenced by Knee X-ray performed during the screening period
• Experiencing pain of the index knee on at least 4 days per week for the last 3 months (based on self-report)
• 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
• Body mass index (BMI) \>18.5 kg/m2 and \<35 kg/m2 on Day 1
• Willingness to abstain from use of restricted medications.
• 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.
• Willing to provide written Informed Consent.

You may not qualify if:

• 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.
• Ipsilateral hip OA such that it would compromise assessment of knee pain.
• Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee.
• 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.
• History or clinical signs and symptoms of infection in the index joint in the last 5 years.
• 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).
• 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).
• Arthroscopy or open knee surgery in the index knee in the previous 12 months or planned for the duration of the study period.
• 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.
• IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
• Any other IA intervention or therapy within 3 months of Screening .
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Swisse Wellness Pty Ltd: lead
• Commonwealth Scientific and Industrial Research Organisation, Australia: collaborator

Study Sites (4)

University of the Sunshine Coast Clinical Trials Centre, Morayfield Health Hub

Morayfield, Queensland, 4506, Australia

Location

University of the Sunshine Coast Clinical Trials Centre, USC Health Clinics

Sippy Downs, Queensland, 4556, Australia

Location

CSIRO Nutrition and Health Research Clinic

Adelaide, South Australia, 5000, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Related Publications (1)

• Stonehouse W, Benassi-Evans B, Bednarz J, Vincent AD, Hall S, Hill CL. Krill oil improved osteoarthritic knee pain in adults with mild to moderate knee osteoarthritis: a 6-month multicenter, randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2022 Sep 2;116(3):672-685. doi: 10.1093/ajcn/nqac125.

  PMID: 35880828 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Lymphoma, Follicular; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Welma Stonehouse, PhD

  Commonwealth Scientific and Industrial Research Organisation, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment arm and Placebo arm

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 30, 2018
• Study Start: February 27, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)