Effect of Omega-3 Fatty Acid on Endothelial Function

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

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.

Study Overview

• Status: Completed
• Conditions: Familial Hypercholesterolemia
• Intervention / Treatment: Drug: placebo; Drug: Omega-3

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

• Norway
  • Bodø, Norway, 8011
    • Division of Internal Medicine, Nordland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omega-3; Omega-3 fatty acids	Drug: Omega-3; Other Names: Omacor
Placebo Comparator: Placebo; Placebo/olive oil	Drug: placebo; Other Names: olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reactive Hyperemia Index (RHI)	Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry	Baseline
Reactive Hyperemia Index (RHI)	Measure of endothelial function	3 months
Reactive Hyperemia Index (RHI)	Measure of endothelial function	6 months
Reactive Hyperemia Index (RHI)	Measure of endothelial function	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Markers of inflammation	Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors	Baseline
Inflammatory markers	Serological markers of inflammation including cytokines, CRP and complement factors	3 months
Inflammatory markers	Serological markers of inflammation including cytokines, CRP and complement factors	6 months
Inflammatory markers	Serological markers of inflammation including cytokines, CRP and complement factors	9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid parameters	Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions	Baseline
Lipid parameters	Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions	3 months
Lipid parameters	Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions	6 months
Lipid parameters	Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions	9 months

Collaborators and Investigators

• Sponsor: Nordlandssykehuset HF
• Collaborators: Pronova BioPharma
• Investigators: Principal Investigator: Knut T Lappegård, MD, PhD, Nordland Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 14, 2013
• First Submitted That Met QC Criteria: March 14, 2013
• First Posted (Estimate): March 18, 2013

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypercholesterolemia; Hyperlipoproteinemia Type II
• Other Study ID Numbers: 2011/899(REK); 2012-000505-68 (EudraCT Number)