NCT01577056

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

1.7 years

First QC Date

April 10, 2012

Last Update Submit

April 11, 2012

Conditions

HypertriglyceridaemiaFamilial Hypercholesterolaemia

Keywords

Familial hypercholesterolaemiaPostprandial dyslipidaemiaFish oil treatmentCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Postprandial changes in triglyceride-rich lipoprotein concentrations

    Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate

    12 weeks

Secondary Outcomes (1)

  • Triglyceride-rich lipoprotein kinetics

    12 weeks

Study Arms (2)

Fish oil

ACTIVE COMPARATOR
Dietary Supplement: Fish oil capsule

Placebo

PLACEBO COMPARATOR

FH subjects with standard treatment (statin treatment)

Drug: HMG Coenzyme reductase

Interventions

Fish oil capsuleDIETARY_SUPPLEMENT

4g Omega capsule for 12 weeks

Also known as: Omacor
Fish oil
HMG Coenzyme reductaseDRUG

All FH subjects are on standard statin treatment during study period

Also known as: Statin
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine & Pharmacology,University of Western Australia

Perth, Western Australia, 6000, Australia

Location

Related Publications (3)

  • Ying Q, Chan DC, Pang J, Croyal M, Blanchard V, Krempf M, Watts GF. Effect of omega-3 fatty acid ethyl esters on postprandial arterial elasticity in patients with familial hypercholesterolemia. Clin Nutr ESPEN. 2023 Jun;55:174-177. doi: 10.1016/j.clnesp.2023.03.012. Epub 2023 Mar 21.

    PMID: 37202042DERIVED

  • Chan DC, Pang J, Barrett PH, Sullivan DR, Mori TA, Burnett JR, van Bockxmeer FM, Watts GF. Effect of omega-3 fatty acid supplementation on arterial elasticity in patients with familial hypercholesterolaemia on statin therapy. Nutr Metab Cardiovasc Dis. 2016 Dec;26(12):1140-1145. doi: 10.1016/j.numecd.2016.07.012. Epub 2016 Aug 3.

    PMID: 27614801DERIVED

  • Chan DC, Pang J, Barrett PH, Sullivan DR, Burnett JR, van Bockxmeer FM, Watts GF. omega-3 Fatty Acid Ethyl Esters Diminish Postprandial Lipemia in Familial Hypercholesterolemia. J Clin Endocrinol Metab. 2016 Oct;101(10):3732-3739. doi: 10.1210/jc.2016-2217. Epub 2016 Aug 4.

    PMID: 27490922DERIVED

MeSH Terms

Conditions

HypertriglyceridemiaHyperlipoproteinemia Type IICardiovascular Diseases

Interventions

Fish OilsOmacorHydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemias

Intervention Hierarchy (Ancestors)

OilsLipidsAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Study Officials

  • Dick Chan, Phd

    The University of Western Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dick Chan, PhD

CONTACT

61-8-92240268dick.chan@uwa.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 13, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations

AU(1)