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Trial registered on ANZCTR


Registration number
ACTRN12611000256976
Ethics application status
Approved
Date submitted
3/03/2011
Date registered
8/03/2011
Date last updated
15/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial to study the effect of a dietary supplement - a novel marine extract (BioLex (Registered Trademark)) - for the treatment of osteoarthritis.
Scientific title
A randomized controlled trial to compare the effect of a novel marine extract (BioLex (Registered Trademark)) with placebo, on measures of pain (VAS) and physical function (Womac) in patients with osteoarthritis of the hip and/or knee.
Secondary ID [1] 259714 0
NIL
Universal Trial Number (UTN)
U1111-1119-6849
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee and/or hip 261290 0
Condition category
Condition code
Musculoskeletal 259437 259437 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New Zealand Green Lipped Muscle (NZGLM) lipid extract blend (BioLex (Registered Trademark))
2 x 150 mg oral capsules, 2 x daily, for 12 weeks
Intervention code [1] 264140 0
Treatment: Other
Comparator / control treatment
Placebo (corn oil)
2 x 150 mg oral capsules, 2 x daily, for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 262245 0
Pain using the Visual Analogue Scale (VAS)
Timepoint [1] 262245 0
Measured at 6, 12, and 15 weeks post intervention.
Primary outcome [2] 262246 0
Physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [2] 262246 0
Measured at 6, 12, and 15 weeks post intervention.
Secondary outcome [1] 273383 0
The Osteoarthritis Quality of Life questionnaire (OAQoL)
Timepoint [1] 273383 0
Measured at 6, 12, and 15 weeks post intervention.
Secondary outcome [2] 273384 0
Four (4) Functional (physical) measures:
i) The stair climb test
ii) The 30 second sit-to-stand test
iii) Walking performance (Walking performance (speed) will be assessed using a stopwatch by calculating walking velocity (m/sec) as participants walk 20 meters)
iv) Tandem Gait test for dynamic balance
Timepoint [2] 273384 0
Measured at 12 weeks post intervention.
Secondary outcome [3] 273385 0
A concomitant medication pill-count of regular pain and anti-inflammatory medication will occur at baseline, weeks 6, 12, and 15. Partcipants will attend an appointment with the research nurse on each occassion and supply all prescribed medication for scrutiny. This will be compared against medication diaries that will be filled out daily by each partcipant.
Timepoint [3] 273385 0
Measured at 6, 12, and 15 weeks post intervention.

Eligibility
Key inclusion criteria
Patients suspected of having Osteoarthritis:

(i) Knee or hip osteoarthritis fulfilling the American College of Rheumatology classification criteria with pain on most days of the past month and radiological changes (osteophytes and joint space narrowing) indicative of OA.
(ii) Overall average hip/groin or knee pain in the last week >30 on 100 mm visual analogue scale (VAS) (to ensure a minimal level of pain);
(iii) Pain in the groin, hip or knee region for more than 3 months;
(iv) Disability related to their arthritis defined as a score of at least 0.5 on the Health Assessment Questionnaire (HAQ)
(v) Aged >18 years.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Hip or knee surgery within past 6 months;
(ii) Awaiting or planning any back or lower limb surgery in the next 3 months;
(iii) Current or recent (in the last 3 months) oral or intraarticular corticosteroid therapy;
(iv) Inflammatory arthritis such as rheumatoid arthritis;
(v) History of hip or knee joint replacement or osteotomy at index joint;
(vi) Other previous hip or knee pathology such as a recent fracture (<3 months) or malignancy at the index joint;
(vii) Other co-existent muscular, joint or neurological condition causing pain or affecting lower limb function (e.g. trauma, shingles);
(viii) Any medical or physical impairment apart from hip or knee OA precluding safe participation in exercise/function based assessments such as uncontrolled hypertension, fibromyalgia, chronic fatigue syndrome or morbid obesity (body mass index > 40);
(ix) Seafood or corn hypersensitivity or allergy;
(x) Inability to comply with study protocol;
(xi) Inadequate written and spoken English;
(xii) Psychiatric illness – major depressive illness or psychosis;
(xiii) Pregnancy;
(xiv) Inter-current acute infections.

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)
All those involved in the study (participants, investigators, and the statistician) will be blinded to allocations until all analyses have been completed. To conceal allocation, consecutively numbered, sealed envelopes will be used and maintained centrally. The statistician will prepare the envelopes kept in a locked location. An envelope will be opened in sequence once the participant has completed all baseline measurements and been accepted into the study, revealing a “batch code” (one of ten possible) which will instruct the research nurse which batch of packages the participant should be provided with. Following data collection, the statistician will be provided with a list of five batch codes for each of the two groups but will otherwise remain blinded as to which is the active group. Each package and its contents will be indistinguishable and identical in appearance, packaging and taste. The research nurse performing the reassessments, along with the participant, will be blinded to the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation to groups will be performed in batches using minimisation by the statistician (who will have no contact with participants nor be involved in recruitment) using participant gender, arthritis severity and age (under 65 and 65+) and a small random component.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3250 0
New Zealand
State/province [1] 3250 0
Otago

Funding & Sponsors
Funding source category [1] 264595 0
Commercial sector/Industry
Name [1] 264595 0
Seperex Nutritionals Limited
Address [1] 264595 0
The Centre for Innovation
87 St. David Street
Dunedin 9054
Country [1] 264595 0
New Zealand
Primary sponsor type
Individual
Name
Dr Tony Schneiders
Address
School of Physiotherapy
325 Great King Street,
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 263734 0
Individual
Name [1] 263734 0
Dr Simon Stebbings
Address [1] 263734 0
Department of Medicine
Dunedin School of Medicine
PO Box 913, Dunedin 9054
Country [1] 263734 0
New Zealand
Other collaborator category [1] 251845 0
Individual
Name [1] 251845 0
Dr Andrew Sansom
Address [1] 251845 0
Seperex Nutritionals Ltd.
The Centre for Innovation
87 St. David Street
Dunedin 9054
Country [1] 251845 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260588 0
Lower South Regional Ethics Committee
Ethics committee address [1] 260588 0
c/- Ministry of Health
229 Moray Place
Dunedin 9016
Ethics committee country [1] 260588 0
New Zealand
Date submitted for ethics approval [1] 260588 0
01/03/2011
Approval date [1] 260588 0
Ethics approval number [1] 260588 0
LRS/11/03/012

Summary
Brief summary
Osteoarthritis (OA) is a chronic, degenerative joint condition, resulting from wear of the articular cartilage. Symptomatic treatment typically involves the use of high dose paracetamol, non-steroidal anti-inflammatory drugs, and/or opiate analgesics; however, these may produce adverse effects. A variety of products derived from the New Zealand Green Lipped Mussel (NZGLM; Perna canaliculus) have been advocated as a treatment for OA on the basis of their reputed anti-inflammatory activity. BioLex (Registered Trademark) contains a novel NZGLM lipid extract and a vegetable oil carrier. The aim of the proposed study is to compare the effects of BioLex (Registered Trademark) with placebo on the signs, symptoms, and quality of life in patients with moderate to severe OA of the hip and/or knee, along with their use of pain relief medication. Specifically the study hypotheses are:

H1: A 12-week course of BioLex (Registered Trademark) will result in significantly greater improvements in pain, physical function, quality of life measures, and physical measures of function than placebo in individuals with OA of the hip and/or knee.

H2: A 12-week course of BioLex (Registered Trademark) will result in reductions in pain and anti-inflammatory medication use compared to placebo in individuals with OA of the hip and/or knee.

H3: BioLex (Registered Trademark) will be associated with fewer adverse effects than standard analgesic regimens.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32295 0
Address 32295 0
Country 32295 0
Phone 32295 0
Fax 32295 0
Email 32295 0
Contact person for public queries
Name 15542 0
Dr Andrew Sansom
Address 15542 0
Seperex Nutritionals Ltd.,
The Centre for Innovation,
87 St. David Street
Dunedin 9054
Country 15542 0
New Zealand
Phone 15542 0
64 3 479 4087
Fax 15542 0
64 3 479 4089
Email 15542 0
andrew.sansom@seperex.co.nz
Contact person for scientific queries
Name 6470 0
Dr Simon Stebbings
Address 6470 0
Department of Medicine
Dunedin School of Medicine
PO Box 913,
Dunedin 9054
Country 6470 0
New Zealand
Phone 6470 0
64 3 474 0999 (ext 8504)
Fax 6470 0
64 3 474 7881
Email 6470 0
simon.stebbings@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary