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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by The University of Western Australia.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Dick C Chan, The University of Western Australia
ClinicalTrials.gov Identifier:
NCT01577056
First received: April 10, 2012
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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 Intervention
Hypertriglyceridaemia
Familial Hypercholesterolaemia
Dietary Supplement: Fish oil capsule
Drug: HMG Coenzyme reductase

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia

Resource links provided by NLM:


Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • Postprandial changes in triglyceride-rich lipoprotein concentrations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate


Secondary Outcome Measures:
  • Triglyceride-rich lipoprotein kinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Kinetic studies of apoB48 and apoB-100 kinetics


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577056

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

Locations
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
Investigators
Principal Investigator: Dick Chan, Phd The University of Western Australia
  More Information

No publications provided

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
Study First Received: April 10, 2012
Last Updated: April 11, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on July 31, 2014