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Osteoarthritis, KneePhase 2NCT03483090

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

A Phase 2 study testing Swisse High Strength Deep Sea Krill Oil in people with Osteoarthritis, Knee, run by Swisse Wellness Pty Ltd at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Swisse High Strength Deep Sea Krill Oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
235 participants
Where
4 sitesAustralia
Study dates
27 Feb 2018to 30 Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • Positive urine dipstick pregnancy test at screening or Day 1, currently pregnant and/or breastfeeding.
  • Women of child bearing potential (WOCBP) who:
  • Are not currently using effective methods of contraception and
  • have not been using effective methods of contraception for 14 days prior to Day 1 and
  • are not willing to use effective methods of contraception throughout the study
  • 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.
  • 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.
  • 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.
  • Known or suspected allergies to the investigational products
  • History of an adverse reaction or known hypersensitivity to seafood or shellfish.
  • 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).

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • CSIRO Nutrition and Health Research Clinic

    Adelaide, South Australia, 5000

  • Emeritus Research

    Camberwell, Victoria, 3124

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

    Morayfield, Queensland, 4506

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

    Sippy Downs, Queensland, 4556

Other trials in Australia

About this study

Official title: A Randomised, Double-blind, Placebo Controlled Study to Investigate the Effect on Knee Pain Reduction and Safety of Swisse High Strength Deep Sea Krill Oil (Superba BOOST) in Adults With Mild to Moderate Osteoarthritis of the Knee

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.

Read more

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.

Being tested
Swisse High Strength Deep Sea Krill Oil, Placebo
Keywords
mild, moderate, krill oil, pain, osteoarthritis, supplement
Medical subject headings
Osteoarthritis, Knee, Lymphoma, Follicular, Pain, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Swisse High Strength Deep Sea Krill OilDietary supplement

    Also called Superba BOOST

    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.

  • PlaceboOther

    No therapeutic effect

Study groups in NCT03483090
Study groupRoleWhat they receive
Treatment AExperimental4000mg Swisse High Strength Deep Sea Krill Oil (Superba BOOST) (4 capsules containing 1000mg each)
Receives: Dietary Supplement: Swisse High Strength Deep Sea Krill Oil
Treatment BPlacebo comparator4 capsules of matching Placebo orally daily (1000mg each of mixed vegetable Oil)
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from Baseline to 6 months

Secondary outcomes (12)

  1. WOMAC B (stiffness subscale) change from Baseline

    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).

    This outcome is measured on the stiffness subscale and will be therefore scored from 0 to 8.

    Measured: from Baseline to 6 months

  2. WOMAC C (function subscale) change from Baseline

    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).

    This outcome is measured on the physical function subscale and will therefore be scored from 0 to 68.

    Measured: from Baseline to 6 months

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

    Venous blood will be taken at baseline, 3 months and 6 months to measure serum cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglycerides. Serum lipid variables will be measured on a Beckman AU480 clinical analyser (Beckman Coulter Inc, Brea, CA, USA) usingcommercial enzymatic test kits for Total cholesterol, triglycerides and HDL-C. LDL-C will be calculated using the Friedewald equation.

    Measured: from Baseline to 6 months

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

    Venous blood will be taken at baseline, 3 months and 6 months to measure interleukin-6, tumour necrosis factor alpha and high sensitivity C-reactive protein. Serum hsCRP will be analysed using a clinical analyser and commercial assays kits (Beckman Coulter, Inc., CA, USA). Serum IL-6 and TNF-α will be analysed using the Luminex 100/200 system with xPONENT software (Luminex, Texas, USA) commercial assay kits.

    Measured: from Baseline to 6 months

  5. Omega 3 index changes from Baseline

    A finger prick dried blood spot sample will be collected for Omega 3 Index analysis using the Aker Biomarine Phlebotomy kit (ARTG 277814). The dried blood spot samples will be shipped to an accredited central clinical laboratory for analysis of fatty acids in dried blood spots and calculation of the Omega-3 Index. This will be collected at baseline, 3 months and 6 months.

    Measured: from Baseline to 6 months

  6. Incidence of SAEs and adverse events (AEs)

    Participants will be questioned, in a non-leading manner, at each visit with regard to any AEs they may have experienced since their last visit. All AEs will be recorded in source documents and will be followed until either completely resolved or until the Final Safety or Early Withdrawal visit.

    Measured: from Baseline to 6 months

  7. Clinically significant changes in haematology from baseline

    The following parameters will be measured at baseline, 3 months and 6 months: Haemoglobin, red blood cell count (RBC), Red cell distribution (RDW), Packed Cell Volume (PCV), Mean Cell Volume (MCV), Mean cell hemoglobin concentration (MCHC), Platelets, White Cell Count (WCC), Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils The medical investigator will assess deviations from laboratory reference ranges for clinical significance.

    Measured: from Baseline to 6 months

  8. Clinically significant changes in biochemistry from baseline

    The following parameters will be measured at baseline, 3 months and 6 months: Sodium, Potassium, Chloride, Bicarbonate, Glucose, Urea, Creatinine, Calcium, C reactive protein (CRP), Uric acid, Phosphate, Albumin, Globulins, Protein, Total bilirubin, Gamma-glutamyl transpeptidase (GGT), Alkaline Phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Lactate Dehyrogenase (LD) The medical investigator will assess deviations from laboratory reference ranges for clinical significance.

    Measured: from Baseline to 6 months

  9. Clinically significant changes in coagulation markers from baseline

    The following parameters will be measured at baseline, 3 months and 6 months: Activated partial thromboplastin time (aPTT) and Prothrombin time (PT) The medical investigator will assess deviations from laboratory reference ranges for clinical significance.

    Measured: from Baseline to 6 months

  10. Use of concomitant medications

    Measured: from Baseline to 6 months

  11. Clinically significant changes on clinical assessments compared to baseline: vital signs

    Blood pressure, pulse, respiratory rate and temperature (°C) will be measured by a designee while the participant is seated. Resting blood pressure and heart rate will be measured using an automated blood pressure monitor in a seated position after a 5-minute rest. The average of three measurements (separated by 2 minutes) will be recorded. Respiratory rate will be measured by counting the number of times the chest rises per minute while the participant is at rest. Body temperature will be measured using a digital tympanic thermometer.Vital signs will be performed at Screening, Baseline, 3 month and 6 month or Early Withdrawal Visit.

    The medical investigator will assess abnormalities for clinical significance.

    Measured: from Baseline to 6 months

  12. Clinically significant changes on clinical assessments: physical examination

    A non-invasive physical examination will be performed by a Medical Investigator and will include the following outcomes: General appearance, Eyes, Ears, nose, mouth and throat, Cardiovascular, Respiratory, Gastrointestinal, Genitourinary•Musculoskeletal•SkinAt Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics. A symptom directed physical exam will be conducted at 6 months or Early Withdrawal Visit.

    The medical investigator will assess abnormalities for clinical significance.

    Measured: from baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study start27 Feb 2018
  3. Primary completion30 Dec 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Treatment arm and Placebo arm
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03483090
Sponsor's protocol ID
SUB-001
Status last verified
Mar 2020
First submitted
27 Feb 2018
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35880828

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Swisse High Strength Deep Sea Krill Oil in people with Osteoarthritis, Knee, run by Swisse Wellness Pty Ltd at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is the change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Pain subscale (Numeric Rating Scale) (time frame: from Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03483090, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.

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