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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03483090
Registration number
NCT03483090
Ethics application status
Date submitted
27/02/2018
Date registered
30/03/2018
Date last updated
18/03/2020
Titles & IDs
Public title
Investigating the Effect of Deep Sea Krill Oil Supplementation in Osteoarthritis of the Knee
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Scientific 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
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Secondary ID [1]
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SUB-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Swisse High Strength Deep Sea Krill Oil
Other interventions - Placebo
Experimental: Treatment A - 4000mg Swisse High Strength Deep Sea Krill Oil (Superba BOOST) (4 capsules containing 1000mg each)
Placebo Comparator: Treatment B - 4 capsules of matching Placebo orally daily (1000mg each of mixed vegetable Oil)
Other interventions: Swisse High Strength Deep Sea Krill Oil
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.
Other interventions: Placebo
No therapeutic effect
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The primary outcome is the change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Pain subscale (Numeric Rating Scale)
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Assessment method [1]
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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.
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Timepoint [1]
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from Baseline to 6 months
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Secondary outcome [1]
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WOMAC B (stiffness subscale) change from Baseline
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Assessment method [1]
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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.
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Timepoint [1]
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from Baseline to 6 months
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Secondary outcome [2]
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WOMAC C (function subscale) change from Baseline
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Assessment method [2]
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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.
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Timepoint [2]
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from Baseline to 6 months
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Secondary outcome [3]
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Serum lipid concentrations (total cholesterol, HDL-C, LDL-C, triglycerides) changes from baseline (efficacy)
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Assessment method [3]
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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.
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Timepoint [3]
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from Baseline to 6 months
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Secondary outcome [4]
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Change in inflammatory markers (IL-6, TNF-a, hsCRP) from Baseline
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Assessment method [4]
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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-a will be analysed using the Luminex 100/200 system with xPONENT software (Luminex, Texas, USA) commercial assay kits.
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Timepoint [4]
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from Baseline to 6 months
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Secondary outcome [5]
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Omega 3 index changes from Baseline
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Assessment method [5]
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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.
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Timepoint [5]
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from Baseline to 6 months
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Secondary outcome [6]
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Incidence of SAEs and adverse events (AEs)
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Assessment method [6]
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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.
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Timepoint [6]
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from Baseline to 6 months
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Secondary outcome [7]
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Clinically significant changes in haematology from baseline
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Assessment method [7]
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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.
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Timepoint [7]
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from Baseline to 6 months
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Secondary outcome [8]
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Clinically significant changes in biochemistry from baseline
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Assessment method [8]
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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.
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Timepoint [8]
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from Baseline to 6 months
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Secondary outcome [9]
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Clinically significant changes in coagulation markers from baseline
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Assessment method [9]
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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.
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Timepoint [9]
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from Baseline to 6 months
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Secondary outcome [10]
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Use of concomitant medications
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Assessment method [10]
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Timepoint [10]
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from Baseline to 6 months
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Secondary outcome [11]
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Clinically significant changes on clinical assessments compared to baseline: vital signs
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Assessment method [11]
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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.
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Timepoint [11]
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from Baseline to 6 months
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Secondary outcome [12]
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Clinically significant changes on clinical assessments: physical examination
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Assessment method [12]
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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.
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Timepoint [12]
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from baseline to 6 months
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Eligibility
Key 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.
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Minimum age
40
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/12/2019
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Sample size
Target
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Accrual to date
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Final
235
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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University of the Sunshine Coast Clinical Trials Centre, Morayfield Health Hub - Morayfield
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Recruitment hospital [2]
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University of the Sunshine Coast Clinical Trials Centre, USC Health Clinics - Sippy Downs
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Recruitment hospital [3]
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CSIRO Nutrition and Health Research Clinic - Adelaide
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Recruitment hospital [4]
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Emeritus Research - Camberwell
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Recruitment postcode(s) [1]
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4506 - Morayfield
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Recruitment postcode(s) [2]
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4556 - Sippy Downs
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3124 - Camberwell
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Swisse Wellness Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Commonwealth Scientific and Industrial Research Organisation, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03483090
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Welma Stonehouse, PhD
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Address
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Commonwealth Scientific and Industrial Research Organisation, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03483090
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