Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001060932
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
11/10/2011
Date last updated
11/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational pilot study of 16 weeks of anti inflammatory doses of fish oils in patients with symptomatic osteoarthritis of the hands and the effect on pain levels
Scientific title
An observational pilot study of 16 weeks of anti inflammatory doses of fish oils in patients with symptomatic osteoarthritis of the hands
Secondary ID [1] 273187 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 4305 0
Condition category
Condition code
Musculoskeletal 4539 4539 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
high dose fish oil, 5 capsules daily for 16 weeks for patients precribed 2.7 - 3.6 grams of combination DHA and EPA by their physicians
Intervention code [1] 4036 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5418 0
Reduction in pain VAS
Timepoint [1] 5418 0
16 weeks
Secondary outcome [1] 9110 0
Musculosketelal Ultrasound of hand joints and the degree of reduction in measures of inflammation
Timepoint [1] 9110 0
16 weeks

Eligibility
Key inclusion criteria
symptomatic osteoarthritis hands with stable doses of analgesics who meet the ACR criteria for osteoarthritis of the hands who are presribed high dose fish oil by their treating doctors
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
prescence of an inflammatory arthritis and subjects unwilling to give informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4481 0
Self funded/Unfunded
Name [1] 4481 0
Country [1] 4481 0
Primary sponsor type
Individual
Name
Eugene Ang
Address
BOX x2213 GPO perth 6847 WA
Country
Australia
Secondary sponsor category [1] 4041 0
None
Name [1] 4041 0
Address [1] 4041 0
Country [1] 4041 0
Other collaborator category [1] 562 0
Hospital
Name [1] 562 0
Royal Perth Hospital
Address [1] 562 0
BOX x2213 GPO perth 6847 WA
Country [1] 562 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6542 0
Royal Perth hospital
Ethics committee address [1] 6542 0
Ethics committee country [1] 6542 0
Australia
Date submitted for ethics approval [1] 6542 0
01/03/2009
Approval date [1] 6542 0
25/01/2010
Ethics approval number [1] 6542 0
EC 2009/019

Summary
Brief summary
THis study is a pilot study to identify the magnitude of response of fish oil to power a larger randomised control trial. It is not intervention in that subjects have already been prescribed fish oil by their treating doctor and we are simply observing this
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29271 0
Address 29271 0
Country 29271 0
Phone 29271 0
Fax 29271 0
Email 29271 0
Contact person for public queries
Name 12518 0
Dr Eugene Ang
Address 12518 0
Royal Perth HospitalBOX x2213 GPO perth 6847 wa
Country 12518 0
Australia
Phone 12518 0
+61 08 9224 7082
Fax 12518 0
Email 12518 0
[email protected]
Contact person for scientific queries
Name 3446 0
Eugene Ang
Address 3446 0
Royal Perth HospitalBOX x2213 GPO perth 6847 WA
Country 3446 0
Australia
Phone 3446 0
+61 08 92247082
Fax 3446 0
Email 3446 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.