Study Results
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Basic Information
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COMPLETED
PHASE3
34 participants
INTERVENTIONAL
2013-03-31
2017-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Omega-3
Omega-3 fatty acids
Omega-3
Placebo
Placebo/olive oil
placebo
Interventions
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Omega-3
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-60 years
* on statin treatment for at least 12 months
Exclusion Criteria
* breast feeding
* cancer
* non-compliance
* PUFA/omega-3 \< 3 months before inclusion
18 Years
60 Years
ALL
No
Sponsors
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Pronova BioPharma
INDUSTRY
Nordlandssykehuset HF
OTHER
Responsible Party
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Principal Investigators
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Knut T Lappegård, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Nordland Hospital
Locations
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Division of Internal Medicine, Nordland Hospital
Bodø, , Norway
Countries
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References
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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.
Other Identifiers
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2012-000505-68
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2011/899(REK)
Identifier Type: -
Identifier Source: org_study_id
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