Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

This study has been terminated.
(Terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Scott Cotler, MD, University of Illinois
ClinicalTrials.gov Identifier:
NCT00845845
First received: February 17, 2009
Last updated: June 18, 2013
Last verified: June 2013
Results First Received: February 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Nonalcoholic Steatohepatitis (NASH)
Hepatic Steatosis
Interventions: Drug: Omega-3-acid ethyl esters (Lovaza)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twelve (12) individuals consented and were screened and nine (9) were randomized between March 2006 and June 2009. Due to low enrollment, the study was terminated in October 2010. Participants were recruited by study staff at outpatient clinics at The University of Illinois Chicago Hospitals and Clinics (UIHC).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A screening evaluation was used prior to group assignment to evaluate whether patients were affected by nonalcoholic steatohepatitis (NASH) and to evaluate the inclusion and exclusion criteria.

Reporting Groups
  Description
Omega-3-acid Ethyl Esters (Lovaza) Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
Placebo Participants receive daily placebo and dietary counseling for 24 weeks

Participant Flow:   Overall Study
    Omega-3-acid Ethyl Esters (Lovaza)     Placebo  
STARTED     3     6  
COMPLETED     3     2  
NOT COMPLETED     0     4  
Lost to Follow-up                 0                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Omega-3-acid Ethyl Esters (Lovaza) Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
Placebo Participants receive daily placebo and dietary counseling for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Omega-3-acid Ethyl Esters (Lovaza)     Placebo     Total  
Number of Participants  
[units: participants]
  3     6     9  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     6     9  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     2     4  
Male     1     4     5  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     1     2     3  
Not Hispanic or Latino     2     4     6  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     3     6     9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)   [ Time Frame: 24 weeks ]

2.  Secondary:   Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated on October 12, 2010 due to low enrollment. Consequently, no analyses were completed.  


Results Point of Contact:  
Name/Title: Scott Cotler, M.D. Professor of Medicine
Organization: The University of Illinois Chicago
phone: 708-216-3789
e-mail: scotler@lumc.edu


Publications:


Responsible Party: Scott Cotler, MD, University of Illinois
ClinicalTrials.gov Identifier: NCT00845845     History of Changes
Other Study ID Numbers: 2003-0601
Study First Received: February 17, 2009
Results First Received: February 6, 2013
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration