Effect of Omega-3 Fatty Acid on Endothelial Function

Phase 3

Completed

• Conditions: Familial Hypercholesterolemia
• Interventions: Drug: Omega-3; Drug: placebo

• Registration Number: NCT01813006
• Lead Sponsor: Nordlandssykehuset HF

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-03
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-18
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Omega-3	Omega-3	Omega-3 fatty acids
Placebo	placebo	Placebo/olive oil

Primary Outcome Measures

Name	Time	Method
Reactive Hyperemia Index (RHI)	9 months	Measure of endothelial function

Secondary Outcome Measures

Name	Time	Method
Markers of inflammation	Baseline	Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors
Inflammatory markers	9 months	Serological markers of inflammation including cytokines, CRP and complement factors

Trial Locations

Locations (1)

Division of Internal Medicine, Nordland Hospital; 🇳🇴 Bodø, Norway