Effect of Omega-3 Fatty Acid on Endothelial Function

Nordlandssykehuset HF

Status and phase: Completed; Phase 3

Conditions: Familial Hypercholesterolemia

Treatments: Drug: placebo; Drug: Omega-3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01813006

2011/899(REK)

2012-000505-68 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Omega-3

Active Comparator group

Description:

Omega-3 fatty acids

Treatment:

Drug: Omega-3

Placebo

Placebo Comparator group

Description:

Placebo/olive oil

Treatment:

Drug: placebo