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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils
Scientific title
Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia
Secondary ID [1] 0 0
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertriglyceridaemia 0 0
Familial Hypercholesterolaemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Study type
Description of intervention(s) / exposure
Other interventions - Fish oil capsule
Treatment: Drugs - HMG Coenzyme reductase

Active Comparator: Fish oil -

Placebo Comparator: Placebo - FH subjects with standard treatment (statin treatment)

Other interventions: Fish oil capsule
4g Omega capsule for 12 weeks

Treatment: Drugs: HMG Coenzyme reductase
All FH subjects are on standard statin treatment during study period

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

Primary outcome [1] 0 0
Postprandial changes in triglyceride-rich lipoprotein concentrations - Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Triglyceride-rich lipoprotein kinetics - Kinetic studies of apoB48 and apoB-100 kinetics
Timepoint [1] 0 0
12 weeks

Key inclusion criteria
- Patients with FH (genetically defined LDL-receptor mutation or Dutch score >8) on
statin treatment only

- Hypertriglyceridaemia on a random blood sample (triglycerides >1.5mml/L)
Minimum age
18 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Subjects with diabetes mellitus

- major systemic illness or use of steroids or other lipid-regulating drugs (such as
niacin, fibrate and colesevelam)

- patients on hypocaloric diets or LDL apheresis; anaemia, haemorrhage and pregnancy.

Study design
Purpose of the study
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 assessing the outcomes
Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
School of Medicine & Pharmacology,University of Western Australia - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
The University of Western Australia
Other collaborator category [1] 0 0
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
The purpose of this study is to determine whether fish oil supplementation is effective in
the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Dick Chan, Phd
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dick Chan, PhD
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