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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01577056




Registration number
NCT01577056
Ethics application status
Date submitted
10/04/2012
Date registered
13/04/2012
Date last updated
13/04/2012

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
NHMRC1028883
Secondary ID [2] 0 0
1028883
Universal Trial Number (UTN)
Trial acronym
FIFH
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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 assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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 in Australia
Recruitment state(s)
WA
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
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/show/NCT01577056
Trial related presentations / publications
Public notes

Contacts
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
61-8-92240268
Fax 0 0
Email 0 0
dick.chan@uwa.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01577056