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Completed

NCT Number: NCT01813006

Effect of Omega-3 Fatty Acid on Endothelial Function

Background

Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease, however its effect on patients with FH is not known.

The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to inflammation measured in the blood and the effect on the blood vessels'ability to relax (endothelial function) by means of tonometry.

Hypothesis

Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the endothelial function, and the treatment will also lead to a decrease in in several markers of inflammation and in lipids in the blood.

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Key information

Conditions

Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Internal Medicine, Nordland Hospital

Bodø, 8011, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • documented familial hypercholesterolemia
  • age 18-60 years
  • on statin treatment for at least 12 months

Exclusion criteria

  • pregnancy or planned pregnancy
  • breast feeding
  • cancer
  • non-compliance
  • PUFA/omega-3 < 3 months before inclusion

Treatment and study plan

Omega-3

Drug

Other names: Omacor

Placebo

Drug

Other names: olive oil

Primary outcomes

  1. Reactive Hyperemia Index (RHI)

    Time frame: Baseline

    Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry

  2. Reactive Hyperemia Index (RHI)

    Time frame: 3 months

    Measure of endothelial function

  3. Reactive Hyperemia Index (RHI)

    Time frame: 6 months

    Measure of endothelial function

  4. Reactive Hyperemia Index (RHI)

    Time frame: 9 months

    Measure of endothelial function

Secondary outcomes

  1. Markers of inflammation

    Time frame: Baseline

    Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors

  2. Inflammatory markers

    Time frame: 3 months

    Serological markers of inflammation including cytokines, CRP and complement factors

  3. Inflammatory markers

    Time frame: 6 months

    Serological markers of inflammation including cytokines, CRP and complement factors

  4. Inflammatory markers

    Time frame: 9 months

    Serological markers of inflammation including cytokines, CRP and complement factors

Other outcomes

  1. Lipid parameters

    Time frame: Baseline

    Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

  2. Lipid parameters

    Time frame: 3 months

    Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

  3. Lipid parameters

    Time frame: 6 months

    Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

  4. Lipid parameters

    Time frame: 9 months

    Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

Sponsors and collaborators

Lead sponsor

Nordlandssykehuset HF

Other

Collaborators

  • Pronova BioPharma

Registry information

Official study title

Effect of Omega-3 Polyunsaturated Fat on Endothelial Function and Inflammatory Parameters in Familial Hypercholesterolemia - a Double Blind, Placebo-controlled Crossover Study

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Mar 18, 2013
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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