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Clinical trials for Polyunsaturated fatty acids

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44347   clinical trials with a EudraCT protocol, of which   7375   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    19 result(s) found for: Polyunsaturated fatty acids. Displaying page 1 of 1.
    EudraCT Number: 2005-002386-37 Sponsor Protocol Number: IVN3ICD Start Date*: 2007-08-24
    Sponsor Name:Department of Cardiology, Aalborg Hospital
    Full Title: Intravenous infusion of n-3 polyunsaturated fatty acids and ventricular tackycardi in patients with implantable cardioverter defibrillator (ICD)
    Medical condition: Patients with an implantable cardioverter defibrillator (ICD-unit) for treatment for cardiac ventricular arrhythmias and for prevention of sudden cardiac death
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002380-90 Sponsor Protocol Number: IVN3DIALYSE Start Date*: 2005-09-26
    Sponsor Name:Nyremedicinsk afdeling, Aalborg Sygehus
    Full Title: Effekten af intravenøs infusion af n-3 polyumættede fedtsyrer på risikomarkører for pludselig hjertedød hos hæmodialysepatienter
    Medical condition: Chronic renal failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003048-37 Sponsor Protocol Number: HSJC-CAR-01-2015 Start Date*: 2015-11-13
    Sponsor Name:Juan Luis Bonilla Palomas
    Full Title: Effect of ?-3 polyunsaturated fatty acids on serum albumin concentration in patients with acute heart failure, hypoalbuminemia, and high inflammatory activity
    Medical condition: Heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004992-37 Sponsor Protocol Number: 2012/1419 Start Date*: 2013-02-25
    Sponsor Name:South-Eastern Norway Regional Health Authority [...]
    1. South-Eastern Norway Regional Health Authority
    2. Oslo University Hospital Rikshospitalet
    Full Title: The effects of n-3 polyunsaturated fatty acids on glomerular filtration rate, proteinuria, fibrosis and inflammation in the kidney transplant and cardiovascular risk markers in kidney transplant re...
    Medical condition: Renal transplantation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002293-28 Sponsor Protocol Number: 2020-002293-28 Start Date*: 2020-05-29
    Sponsor Name:Karolinska University Hospital
    Full Title: Resolving inflammatory storm in COVID-19 patients by Omega-3 polyunsaturated fatty acids. - A single-blind, randomized, placebo-controlled feasibility study
    Medical condition: SARS-COV-2 Infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084272 SARS-CoV-2 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-005287-94 Sponsor Protocol Number: Stulnig_PUFA1 Start Date*: 2008-05-06
    Sponsor Name:Medizinische Universität Wien
    Full Title: Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients
    Medical condition: morbid obesity
    Disease: Version SOC Term Classification Code Term Level
    8.1 10027966 Morbid obesity LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001975-36 Sponsor Protocol Number: 201200197536 Start Date*: 2012-05-24
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: Evaluation on the efficacy of docosahexaenoic acid for the treatment of nonalcoholic fatty liver disease in children
    Medical condition: Nonalcoholic steatohepatitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10027433 Metabolism and nutrition disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-003029-11 Sponsor Protocol Number: 2012-489 Start Date*: 2012-09-10
    Sponsor Name:Steen Stender
    Full Title: Ethyl ester Versus Triglyceride formulations of long chained omega-3 fatty acids in moderate hypertriglyceridemia - a randomized placebo-controlled clinical trial (EVT)
    Medical condition: Hypertriglyceridemia
    Disease: Version SOC Term Classification Code Term Level
    15.0 10027433 - Metabolism and nutrition disorders 10071235 Combined hyperlipidemia LLT
    15.0 10010331 - Congenital, familial and genetic disorders 10060754 Type IV hyperlipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-003853-13 Sponsor Protocol Number: HPEPA-01 Start Date*: 2005-01-13
    Sponsor Name:Hela Pharma AB
    Full Title: Placebo controlled, randomised, double-blind, multicentre study of PlusEPA (a PUFA, Polyunsaturated Fatty Acids, supplement) as treatment for ADHD (combined type) with co-morbidity in Swedish child...
    Medical condition: ADHD (combined type) and co-morbidity in children
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-000046-31 Sponsor Protocol Number: Omega18-13-03 Start Date*: 2011-11-29
    Sponsor Name:The Sahlgrenska Center for Pediatric Ophtalmology Research
    Full Title: A randomised Intervention, Single-Center Study to Determine the Role of Fatty Acids in Serum in preventing Retinopathy of Prematurity
    Medical condition: Premature male/female infants, <28 gestational weeks at birth with risk of developing retinopathy of prematurity (ROP)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-011106-42 Sponsor Protocol Number: 2008MZ09B Start Date*: 2009-06-25
    Sponsor Name:Institute for Clinical and Experimental Medicine
    Full Title: Aditive effects of omega-3 polyunsaturated fatty acids and pioglitazone in the treatment of type 2 diabetes mellitus
    Medical condition: The project deals with hummoral and metabolic aspects of insulin resistance (IR), which is assumed to be the basic metabolic disorder which leads to the development of type 2 diabetes mellitus (T2D...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-011819-20 Sponsor Protocol Number: V00067 CA 201 1A Start Date*: 2009-05-29
    Sponsor Name:Pierre Fabre Médicament
    Full Title: Effects of OMACOR in patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome. A proof of concept study.
    Medical condition: Adult patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome, with implantable cardioverter defibrillator (ICD).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057926 Long QT syndrome congenital LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-023071-25 Sponsor Protocol Number: OmexaStudy10 Start Date*: 2011-06-02
    Sponsor Name:Daniel Podzamczer Palter
    Full Title: cambios en la densitometría mineral ósea en pacientes infectados por VIH. Estudio aleatorizado con ácidos grasos poliinsaturados n-3. changes in bone mineral densitometry HIV-infected patients. Ran...
    Medical condition: La enfermedad investigada es el VIH, se administrará el fármaco a pacientes que presenten hipertrigliceridémia secundaria a los TARGA y se evaluaran los efectos del MI sobre el metabolismo óseo, qu...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-004155-38 Sponsor Protocol Number: HU01/PNE/MUCO1 Start Date*: 2008-10-21
    Sponsor Name:Hôpital Universitaire Des Enfants Reine Fabiola (H.U.D.E.R.F.)
    Full Title: Biochemical effects of a long-term supplementation with omega-3 polyunsaturated fatty acids in cystic fibrosis
    Medical condition: cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10011762 Cystic fibrosis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001034-14 Sponsor Protocol Number: 07/Q0803/31 Start Date*: 2007-08-10
    Sponsor Name:St George's Healthcare NHS Trust [...]
    1. St George's Healthcare NHS Trust
    2. SLA Pharma
    Full Title: The effect of omega-3 fatty acids on Barrett's oesophagus
    Medical condition: Barrett's oesophagus refers to changes in the lining of the lower oesophagus in response to injury caused by gastric reflux. It is a pre-malignant condition and has a well established link with ad...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004134 Barrett's esophagus LLT
    9.1 10004136 Barrett's oesophagitis with dysplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-018054-33 Sponsor Protocol Number: 09-001 Start Date*: 2010-06-21
    Sponsor Name:Faculty of Pharmacy, University of Ljubljana
    Full Title: Efficacy of vitamin E and omega-3 unsaturated fatty acid in prevention of damage induced by oxidative stress in patients with schizophrenia
    Medical condition: Patients diagnosed with schizophrenia chronically treated with depo haloperidol will be randomly assigned to four arms; i) placebo, ii) vitamin E (1200 IU/day), iii) omega-3 (360 mg/day EPA, 240 mg...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10039626 Schizophrenia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: View results
    EudraCT Number: 2011-003633-33 Sponsor Protocol Number: MAXEPA01 Start Date*: 2011-09-29
    Sponsor Name:Central Manchester University Hospitals NHS Foundation Trust
    Full Title: The effect of purified fish oils on glucose regulation in Congenital Hyperinsulinism of Infancy (CHI)
    Medical condition: Congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10062329 Congenital endocrine anomaly PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-020464-38 Sponsor Protocol Number: PRENU Start Date*: 2010-06-08
    Sponsor Name:University of Oslo
    Full Title: Nutrition, growth and development among very preterm infants
    Medical condition: The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids DHA and AA to Very Low Birth Weight Infants...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NO (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-005385-38 Sponsor Protocol Number: GFT505-315-1 Start Date*: 2016-03-04
    Sponsor Name:Genfit SA
    Full Title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis.
    Medical condition: Non-Alcoholic Steatohepatitis (NASH) and fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10016642 Fibrosis PT
    22.0 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) GB (Completed) DE (Completed) CZ (Prematurely Ended) SE (Completed) IT (Prematurely Ended) PT (Completed) NL (Completed) DK (Prematurely Ended) FI (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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