Effect of Omega-3 Fatty Acid on Endothelial Function

Familial Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813006
• Other study ID #: 2011/899(REK)
• Secondary ID: 2012-000505-68
• Status: Completed
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2013
• Source: Nordlandssykehuset HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Drug:
• Omega-3

• placebo

Locations

Country	Name	City	State
Norway	Division of Internal Medicine, Nordland Hospital	Bodø

Sponsors (2)

Lead Sponsor	Collaborator
Nordlandssykehuset HF	Pronova BioPharma

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipid parameters	Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions	Baseline
Other	Lipid parameters	Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions	3 months
Other	Lipid parameters	Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions	6 months
Other	Lipid parameters	Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions	9 months
Primary	Reactive Hyperemia Index (RHI)	Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry	Baseline
Primary	Reactive Hyperemia Index (RHI)	Measure of endothelial function	3 months
Primary	Reactive Hyperemia Index (RHI)	Measure of endothelial function	6 months
Primary	Reactive Hyperemia Index (RHI)	Measure of endothelial function	9 months
Secondary	Markers of inflammation	Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors	Baseline
Secondary	Inflammatory markers	Serological markers of inflammation including cytokines, CRP and complement factors	3 months
Secondary	Inflammatory markers	Serological markers of inflammation including cytokines, CRP and complement factors	6 months
Secondary	Inflammatory markers	Serological markers of inflammation including cytokines, CRP and complement factors	9 months