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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-4njyw9 |
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Date of registration:
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05/06/2012 |
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Primary sponsor: |
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Public title:
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Effects of fish oil supplementation on pre diabetes in patients with chronic hepatitis C.
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Scientific title:
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Effects of omega 3 fatty acids supplementation on insulin resistance in patients with chronic hepatitis C. |
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Date of first enrolment:
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05/05/2011 |
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Target sample size:
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100 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-4njyw9/ |
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Study type:
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Study design:
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Clinical trial, randomized, parallel, blinded, with two arms.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Thiago
Freire |
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Address:
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Rua: Araújo Pinho, 32-Canela
40.110.150
Salvador
Brazil |
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Telephone:
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71-87201222 |
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Email:
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thiagonofre@yahoo.com.br |
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Affiliation:
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Universidade Federal da Bahia |
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Name:
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Thiago
Freire |
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Address:
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Rua: Araújo Pinho, 32-Canela
40.110.150
Salvador
Brazil |
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Telephone:
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71-87201222 |
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Email:
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thiagonofre@yahoo.com.br |
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Affiliation:
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Universidade Federal da Bahia |
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Key inclusion & exclusion criteria
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Inclusion criteria: Adults (age > 18 years) diagnosed with chronic hepatitis C (genotype I); either non responders or naive patients; alcohol consumption < 40g/dia; HOMA index > 2.5; Signature of term consent
Exclusion criteria: Diabetics or those using drugs to alleviate insulin resistance, co-infected (HIV or HBV), hepatitis with autoimmune or use of antiviral treatment (interferon and ribavirin), decompensated liver disease or patients with hepatocellular carcinoma; With other neoplasias; Patients with chronic renal failure or decompensated heart failure.
Age minimum:
18Y
Age maximum:
100Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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A00-B99
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Hepatitis C virus-infected patients, insulin resistance
B18.2
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Intervention(s)
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Patients (n-100) will receive basic nutritional orientations based on healthy eating and will be divided into two groups according to the type of supplementation with either omega-3 (1080mg of EPA plus 720mg of DHA) polyunsaturated fatty acids (fish oil - Test Group) or 1800mg of soybean oil (control group) for 12 weeks.
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Primary Outcome(s)
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Reduction of insulin resistance, according Homa, in patients with chronic hepatitis C after supplementation with omega 3 fatty acids
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Secondary Outcome(s)
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Reduction of inflammatory cytokines (IL-1,IL-6, TNF) in patients with chronic hepatitis C after supplementation with omega 3 fatty acids
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Secondary ID(s)
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065/2010
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CAAE 0045.0.442.000-10
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Source(s) of Monetary Support
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FAPESB - Salvador, BA, Brazil
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