Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-02-29
2020-06-30
Brief Summary
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Detailed Description
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panel of biochemistry and liver function tests: triglycerides, cholesterol, HDLcholesterol, LDL-cholesterol, glucose, insulin, serum bilirubin, liver tests, thyroid hormones, bile acids and their metabolites, albumin, total protein.
Bioactive metabolites, Inflammatory markers Non-invasive serum markers of liver fibrosis and steatohepatitis. Hyaluronic acid, NAFLD fibrosis score, cytokeratine-18 fragments. Ultrasonography with non-invasive measurement of fibrosis and steatosis, magnetic resonance spectroscopy for visceral and liver fat determination.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Polyunsaturated omega-3 fatty acids
Patients will receive n-3 fatty acids (Maxicor) 3,6 g/day.
Maxicor
Patients with NAFLD will be randomly allocated to receive or n-3 PUFA (3,6 g/day, oral treatment) or placebo (1:1).
Placebo
Patients will receive placebo (soya oil)
Placebo
Patients with NAFLD will be randomly allocated to receive or placebo or n-3 PUFA for 12 months (1:1).
Interventions
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Maxicor
Patients with NAFLD will be randomly allocated to receive or n-3 PUFA (3,6 g/day, oral treatment) or placebo (1:1).
Placebo
Patients with NAFLD will be randomly allocated to receive or placebo or n-3 PUFA for 12 months (1:1).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Gravidity
* Incompliance.
18 Years
ALL
No
Sponsors
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General University Hospital, Prague
OTHER
Responsible Party
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Radan Bruha
Clinical associated professor
Principal Investigators
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Radan Bruha, MD
Role: PRINCIPAL_INVESTIGATOR
General University Hospital, Prague
Locations
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General University Hospital
Prague, Prague 2, Czechia
Countries
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References
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Smid V, Dvorak K, Sedivy P, Kosek V, Lenicek M, Dezortova M, Hajslova J, Hajek M, Vitek L, Bechynska K, Bruha R. Effect of Omega-3 Polyunsaturated Fatty Acids on Lipid Metabolism in Patients With Metabolic Syndrome and NAFLD. Hepatol Commun. 2022 Jun;6(6):1336-1349. doi: 10.1002/hep4.1906. Epub 2022 Feb 11.
Other Identifiers
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15-28745A
Identifier Type: -
Identifier Source: org_study_id
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