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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000505-68 | EudraCT Number |
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| Name | Class |
|---|---|
| Pronova BioPharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 | Active Comparator | Omega-3 fatty acids |
|
| Placebo | Placebo Comparator | Placebo/olive oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Drug |
|
| |
| placebo |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knut T Lappegård, MD, PhD | Nordland Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Internal Medicine, Nordland Hospital | Bodø | 8011 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36999528 | Derived | Hande LN, Thunhaug H, Ludviksen J, Hovland A, Lappegard KT. No effect of omega-3 polyunsaturated fatty acid supplementation on inflammatory markers in familial hypercholesterolemia: a randomized crossover trial. Scand J Clin Lab Invest. 2023 May;83(3):152-159. doi: 10.1080/00365513.2023.2178499. Epub 2023 Mar 31. |
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| C405603 | Omacor |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Drug |
|
|
| 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 |
| 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 |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |