Omega 3 Supplementation in Fatty Liver (OMEGA 3 NASH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Pinto Marques Oliveira, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01992809
First received: November 7, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

Nonalcoholic fatty liver disease (NAFLD) is a clinical and pathological condition, whose spectrum can range from steatosis to steatohepatitis and cirrhosis, in patients without a history of alcohol abuse. Nonalcoholic steatohepatitis (NASH), the severe form of (NAFLD), has emerged as a clinically important type of chronic liver disease in industrialized countries and is characterized pathologically by hepatocellular ballooning, Mallory's hyaline, scattered inflammation and perisinusoidal fibrosis. NASH associated with cirrhosis can decompensate into subacute liver failure, progress to hepatocellular cancer and reoccur post transplantation.In the absence of established treatment, therapy is generally directed to treatment of risk factors for metabolic syndrome. Recently, some studies have been demonstrated that Polyunsaturated fatty acids (PUFAs), omega3 type, could reduced TNFalfa, IL6, aminotransferases, insulin resistance and steatosis verified by ultrasound. Neverthless, this is the first study that evaluate liver histology after six months of PUFA (omega3) in the treatment of patients with NASH.


Condition Intervention Phase
Fatty Liver
Dietary Supplement: Omega 3
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Polyunsaturated Fatty Acid (Pufa) Omega 3 in the Reduction of the Inflammatory Component of the Nonalcoholic Steatohepatitis (Nash):Randomized Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Efficacy in reduce inflammatory component of NASH for NAS score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine the efficacy of Omega-3 fatty acid in reducing the inflammatory component of NASH for liver through liver biopsy NAS score.


Secondary Outcome Measures:
  • Inflammatory systemic profile [ Time Frame: 6 mothns ] [ Designated as safety issue: No ]
    Measure TNFalfa, IL6, adiponectin, lipidic leuckocyte profile, EPA (eicosapentaenoic acid), DHA (docosahexaenoic) and laboratory tests AST, ALT, Cholesterol, total triglycerides, PCR, VHS, SAA.


Enrollment: 60
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omega 3
Omega-3 group (n=30) received capsules containing 945 mg of Omega-3 PUFA [α linolenic acid/ 64%, eicosapentaenoic acid (EPA)/16% and docosahexaenoic acid (DHA)/21%], in 3 capsules/ day
Dietary Supplement: Omega 3
Omega-3 group (n=30) received capsules containing 945 mg of Omega-3 PUFA [α linolenic acid/ 64%, eicosapentaenoic acid (EPA)/16% and docosahexaenoic acid (DHA)/21%], in 3 capsules/ day
Placebo Comparator: placebo mineral oil
placebo mineral oil 3 ml/day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-70 years of age, both sexes
  • With or without non-insulin-dependent diabetes or glucose intolerance
  • Absence of alcoholism <20g (women) and <40g (men) of ethanol/day, drugs, schistosomiasis, hepatitis B or C and other chronic liver diseases cause determined
  • Absence of autoantibodies and rates of copper and ceruloplasmin normal
  • Biopsy-liver until 12 months previous, showing steatosis, lobular inflammatory infiltrate and ballooning of hepatocytes, which may be present or not Mallory's corpuscles and liver fibrosis stage I and II, NAS score> 5;
  • Patients who agree to participate in the study and all signed informed consent.

Exclusion Criteria:

  • Poisoning by exogenous oxidants
  • Pregnancy and lactation
  • Prothrombin time <70% or platelet count <70 000/mm3, or any bleeding disorders, including alteration of the bleeding time
  • Refusal to cooperate with research
  • steatosis without signs of inflammation or ballooning or cirrhosis (stage IV)
  • diabetes mellitus using insulin
  • allergy to fish or flaxseed
  • anti-inflammatory use of non-hormonal
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01992809

Locations
Brazil
University of Sao Paulo School of Medicine
Sao Paulo, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: CLAUDIA PM OLIVEIRA, MD, PhD University of Sao Paulo, School of Medicine
  More Information

No publications provided

Responsible Party: Claudia Pinto Marques Oliveira, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01992809     History of Changes
Other Study ID Numbers: 0681/09CAPPESQ
Study First Received: November 7, 2013
Last Updated: November 19, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Nonalcoholic fatty liver
omega 3

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014