Effect of Omega-3 Fatty Acid on Endothelial Function

Study Overview
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Brief Summary
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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.

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

Conditions
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Familial Hypercholesterolemia

Intervention / Treatment
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* Drug: Omega-3
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3<br>Omega-3 fatty acids | Drug: Omega-3<br> <br> * Other names: Omacor;|
| Placebo Comparator: Placebo<br>Placebo/olive oil | Drug: placebo<br> <br> * Other names: olive oil;|

What is the study measuring?
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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 |