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Trial record 17 of 282 for:    Non-alcoholic Steatohepatitis | United States

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

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ClinicalTrials.gov Identifier: NCT00845845
Recruitment Status : Terminated (Terminated due to low enrollment.)
First Posted : February 18, 2009
Results First Posted : July 24, 2013
Last Update Posted : July 24, 2013
Sponsor:
Information provided by (Responsible Party):
Scott Cotler, MD, University of Illinois at Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Nonalcoholic Steatohepatitis (NASH)
Hepatic Steatosis
Interventions Drug: Omega-3-acid ethyl esters (Lovaza)
Drug: Placebo
Enrollment 12
Recruitment Details 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 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.
Arm/Group Title Omega-3-acid Ethyl Esters (Lovaza) Placebo
Hide Arm/Group Description Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks Participants receive daily placebo and dietary counseling for 24 weeks
Period Title: Overall Study
Started 3 6
Completed 3 2
Not Completed 0 4
Reason Not Completed
Lost to Follow-up             0             4
Arm/Group Title Omega-3-acid Ethyl Esters (Lovaza) Placebo Total
Hide Arm/Group Description Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks Participants receive daily placebo and dietary counseling for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 3 6 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
6
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 9 participants
Female
2
  66.7%
2
  33.3%
4
  44.4%
Male
1
  33.3%
4
  66.7%
5
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 9 participants
Hispanic or Latino
1
  33.3%
2
  33.3%
3
  33.3%
Not Hispanic or Latino
2
  66.7%
4
  66.7%
6
  66.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 6 participants 9 participants
3 6 9
1.Primary Outcome
Title Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.
Arm/Group Title Omega-3-acid Ethyl Esters (Lovaza) Placebo
Hide Arm/Group Description:
Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
Participants receive daily placebo and dietary counseling for 24 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.
Arm/Group Title Omega-3-acid Ethyl Esters (Lovaza) Placebo
Hide Arm/Group Description:
Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
Participants receive daily placebo and dietary counseling for 24 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were captured using a systematic assessment from baseline (week 0) through week 24 for both the treatment and placebo groups.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omega-3-acid Ethyl Esters (Lovaza) Placebo
Hide Arm/Group Description Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks Participants receive daily placebo and dietary counseling for 24 weeks
All-Cause Mortality
Omega-3-acid Ethyl Esters (Lovaza) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Omega-3-acid Ethyl Esters (Lovaza) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/6 (0.00%)    
Infections and infestations     
Herpes zoster  [1]  1/3 (33.33%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Herpes zoster is also known as shingles.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Omega-3-acid Ethyl Esters (Lovaza) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      0/6 (0.00%)    
Gastrointestinal disorders     
Diarrhea   2/3 (66.67%)  2 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
The study was terminated on October 12, 2010 due to low enrollment. Consequently, no analyses were completed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Cotler, M.D. Professor of Medicine
Organization: The University of Illinois Chicago
Phone: 708-216-3789
EMail: scotler@lumc.edu
Publications:
Layout table for additonal information
Responsible Party: Scott Cotler, MD, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00845845     History of Changes
Other Study ID Numbers: 2003-0601
First Submitted: February 17, 2009
First Posted: February 18, 2009
Results First Submitted: February 6, 2013
Results First Posted: July 24, 2013
Last Update Posted: July 24, 2013