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Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils (FIFH)

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ClinicalTrials.gov Identifier: NCT01577056
Recruitment Status : Unknown
Verified April 2012 by Dick C Chan, The University of Western Australia.
Recruitment status was:  Not yet recruiting
First Posted : April 13, 2012
Last Update Posted : April 13, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypertriglyceridaemia Familial Hypercholesterolaemia Dietary Supplement: Fish oil capsule Drug: HMG Coenzyme reductase

Detailed Description:

The use of statin therapy in familial hypercholesterolaemia (FH) is known to reduce cardiovascular risk and is a first line recommendation, however, there is considerable residual risk predicted by the presence of fasting and post-prandial hypertriglyceridaemia.

This study will examine the effect of oral n-3 fatty acid ethyl esters supplementation (4g/day, Omacor) on postprandial hypertriglyceridaemia and post-prandial arterial function when administrated to FH patients at increased risk of cardiovascular disease due to their residual fasting hypertriglyceridaemia.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia
Study Start Date : April 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Fish oil Dietary Supplement: Fish oil capsule
4g Omega capsule for 12 weeks
Other Name: Omacor
Placebo Comparator: Placebo
FH subjects with standard treatment (statin treatment)
Drug: HMG Coenzyme reductase
All FH subjects are on standard statin treatment during study period
Other Name: Statin

Outcome Measures

Primary Outcome Measures :
  1. Postprandial changes in triglyceride-rich lipoprotein concentrations [ Time Frame: 12 weeks ]
    Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate

Secondary Outcome Measures :
  1. Triglyceride-rich lipoprotein kinetics [ Time Frame: 12 weeks ]
    Kinetic studies of apoB48 and apoB-100 kinetics

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577056

Contact: Dick Chan, PhD 61-8-92240268 dick.chan@uwa.edu.au

Australia, Western Australia
School of Medicine & Pharmacology,University of Western Australia Not yet recruiting
Perth, Western Australia, Australia, 6000
Contact: Dick Chan, PhD    61-8-92240268    dick.chan@uwa.edu.au   
Sponsors and Collaborators
The University of Western Australia
National Health and Medical Research Council, Australia
Principal Investigator: Dick Chan, Phd The University of Western Australia
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dick C Chan, Assistant Professor, The University of Western Australia
ClinicalTrials.gov Identifier: NCT01577056     History of Changes
Other Study ID Numbers: 1028883
NHMRC1028883 ( Other Grant/Funding Number: NHMRC )
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012

Keywords provided by Dick C Chan, The University of Western Australia:
Familial hypercholesterolaemia
Postprandial dyslipidaemia
Fish oil treatment
Cardiovascular disease

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn