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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - Fish oil capsule
Treatment: Drugs - HMG Coenzyme reductase

Active comparator: Fish oil -

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


Treatment: Other: 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
Treatment: Other
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
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Triglyceride-rich lipoprotein 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
Sex
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2014
Actual
Sample size
Target
30
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
Trial website
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
[email protected]
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01577056