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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
SUB-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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)


Treatment: Other: 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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary outcome is the change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Pain subscale (Numeric Rating Scale)
Timepoint [1] 0 0
from Baseline to 6 months
Secondary outcome [1] 0 0
WOMAC B (stiffness subscale) change from Baseline
Timepoint [1] 0 0
from Baseline to 6 months
Secondary outcome [2] 0 0
WOMAC C (function subscale) change from Baseline
Timepoint [2] 0 0
from Baseline to 6 months
Secondary outcome [3] 0 0
Serum lipid concentrations (total cholesterol, HDL-C, LDL-C, triglycerides) changes from baseline (efficacy)
Timepoint [3] 0 0
from Baseline to 6 months
Secondary outcome [4] 0 0
Change in inflammatory markers (IL-6, TNF-a, hsCRP) from Baseline
Timepoint [4] 0 0
from Baseline to 6 months
Secondary outcome [5] 0 0
Omega 3 index changes from Baseline
Timepoint [5] 0 0
from Baseline to 6 months
Secondary outcome [6] 0 0
Incidence of SAEs and adverse events (AEs)
Timepoint [6] 0 0
from Baseline to 6 months
Secondary outcome [7] 0 0
Clinically significant changes in haematology from baseline
Timepoint [7] 0 0
from Baseline to 6 months
Secondary outcome [8] 0 0
Clinically significant changes in biochemistry from baseline
Timepoint [8] 0 0
from Baseline to 6 months
Secondary outcome [9] 0 0
Clinically significant changes in coagulation markers from baseline
Timepoint [9] 0 0
from Baseline to 6 months
Secondary outcome [10] 0 0
Use of concomitant medications
Timepoint [10] 0 0
from Baseline to 6 months
Secondary outcome [11] 0 0
Clinically significant changes on clinical assessments compared to baseline: vital signs
Timepoint [11] 0 0
from Baseline to 6 months
Secondary outcome [12] 0 0
Clinically significant changes on clinical assessments: physical examination
Timepoint [12] 0 0
from baseline to 6 months

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.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2019
Sample size
Target
Accrual to date
Final
235
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
University of the Sunshine Coast Clinical Trials Centre, Morayfield Health Hub - Morayfield
Recruitment hospital [2] 0 0
University of the Sunshine Coast Clinical Trials Centre, USC Health Clinics - Sippy Downs
Recruitment hospital [3] 0 0
CSIRO Nutrition and Health Research Clinic - Adelaide
Recruitment hospital [4] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
4506 - Morayfield
Recruitment postcode(s) [2] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Swisse Wellness Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03483090
Trial related presentations / 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. Erratum In: Am J Clin Nutr. 2022 Nov;116(5):1454. doi: 10.1093/ajcn/nqac262.
Public notes

Contacts
Principal investigator
Name 0 0
Welma Stonehouse, PhD
Address 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03483090