Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000641695
Ethics application status
Approved
Date submitted
12/10/2005
Date registered
14/10/2005
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of DPA in comparison to DHA in lowering plasma triglyceride levels and other cardiovascular risk factors
Scientific title
A randomised trial to evaluate the effects of DPA supplementation in the treatment of hypertriglyceridemia to reduce the risk of cardiovascular disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertriglyceridaemic subjects 771 0
Condition category
Condition code
Cardiovascular 847 847 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a dietary supplementation of docosapentaenoic acid (DPA) in comparison to docosahexaenoic acid (DHA) for 6 weeks duration in hypertriglyceridemic subjects to assess the efficacy of triglyceride lowering effect.
Intervention code [1] 714 0
None
Comparator / control treatment
Placebo controlled (sunola oil)
Control group
Active

Outcomes
Primary outcome [1] 1086 0
Assess the ability of DPA to lower plasma triglyceride levels in people with elevated plasma triglyceride levels.
Timepoint [1] 1086 0
Fasting plasma triglycerides will be measured on two consecutive days at week 0 and then again at week 6 of intervention.
Secondary outcome [1] 2020 0
Assess the ability of dietary DPA on platelet aggregation (whole blood agonist induced ex vivo aggregation).
Timepoint [1] 2020 0
At weeks 0 and 2 of intervention.

Eligibility
Key inclusion criteria
Subjects with hypertriglyceridemia.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software microsoft excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study also contains a third Placebo group where the placebo is sunola oil which does not contain DPA and DHA
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2005
Actual
8/08/2005
Date of last participant enrolment
Anticipated
Actual
26/08/2005
Date of last data collection
Anticipated
Actual
28/07/2006
Sample size
Target
90
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 933 0
Commercial sector/Industry
Name [1] 933 0
Meat & Livestock Australia
Country [1] 933 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 792 0
University
Name [1] 792 0
RMIT University
Address [1] 792 0
Country [1] 792 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302018 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 302018 0
Ethics committee country [1] 302018 0
Australia
Date submitted for ethics approval [1] 302018 0
07/04/2005
Approval date [1] 302018 0
27/04/2005
Ethics approval number [1] 302018 0
HE05/047

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36268 0
Address 36268 0
Country 36268 0
Phone 36268 0
Fax 36268 0
Email 36268 0
Contact person for public queries
Name 9903 0
Barbara Meyer
Address 9903 0
Department of Biomedical Science
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 9903 0
Australia
Phone 9903 0
+61 2 42213459
Fax 9903 0
Email 9903 0
[email protected]
Contact person for scientific queries
Name 831 0
Barbara Meyer
Address 831 0
Department of Biomedical Science
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 831 0
Australia
Phone 831 0
+61 2 42213459
Fax 831 0
Email 831 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.