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

T

The University of Western Australia

Status

Unknown

Conditions

Familial Hypercholesterolaemia
Hypertriglyceridaemia

Treatments

Dietary Supplement: Fish oil capsule
Drug: HMG Coenzyme reductase

Study type

Interventional

Funder types

Other

Identifiers

NCT01577056
NHMRC1028883 (Other Grant/Funding Number)
1028883

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups, including a placebo group

Fish oil
Active Comparator group
Treatment:
Dietary Supplement: Fish oil capsule
Placebo
Placebo Comparator group
Description:
FH subjects with standard treatment (statin treatment)
Treatment:
Drug: HMG Coenzyme reductase

Trial contacts and locations

0

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Central trial contact

Dick Chan, PhD

Data sourced from clinicaltrials.gov

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