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Trial record 40 of 581 for:    bilirubin AND liver function

Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191177
Recruitment Status : Withdrawn (no subjects recruited)
First Posted : August 30, 2010
Last Update Posted : June 22, 2017
Harvard University
Information provided by (Responsible Party):
Tom Jaksic, Boston Children’s Hospital

Brief Summary:
The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not

Condition or disease Intervention/treatment Phase
Liver Disease Short Bowel Syndrome Drug: Lovaza (omega-3-acid ethyl ester) Dietary Supplement: Corn oil Phase 1 Phase 2

Detailed Description:
This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An Initial Trial of Enteral Fish Oil Supplementation in the Treatment of Parenteral Nutrition-associated Liver Disease in Patients With Short Bowel Syndrome
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: Lovaza group
Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day
Drug: Lovaza (omega-3-acid ethyl ester)
supplied as 1gram transparent soft-gelatin capsules filled with yellow oil, dosage is 1gram per kilogram of body weight per day, not exceeding 4grams per day until normalization of liver function test
Other Name: fish oil

Placebo Comparator: Placebo group
Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day
Dietary Supplement: Corn oil
1 gram per kilogram body weight per day, not exceeding 4 grams

Primary Outcome Measures :
  1. Normalization of ALT
    The primary aim is to examine the efficacy of Lovaza, when compared to placebo, on normalizing liver function, as measured primarily by amino alanine transferase (ALT). The investigators believe that patients in the Lovaza group will normalize ALT faster than in the placebo group.

Secondary Outcome Measures :
  1. Normalization other liver function tests and inflammatory status
    The investigators believe that Lovaza will result in faster reduction of the serum levels of the following markers: total bilirubin, aspartate amino transferase (AST), alkaline phosphatase, gamma glutamyl transpeptidase (GGTP) & C-reactive protein (CRP).

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of parenteral nutrition(PN)administration >4weeks
  • PN associated liver disease from intestinal failure
  • ability to take full enteral feed
  • body weight equal or greater than 3kg
  • elevated ALT level twice of that normal(ALT>84)at the time PN is weaned off

Exclusion Criteria:

  • Hemodynamic instability
  • renal failure
  • suspected congenital obstruction of the hepatobiliary system
  • diagnosis hepatitis A, B, or C
  • diagnosis of alpha 1-antitrypsin deficiency
  • diagnosis of cytomegalovirus infection
  • diagnosis of HIV
  • children in care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191177

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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Harvard University
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Principal Investigator: Tom Jaksic, MD, PhD Children's Hopsital Boston

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Responsible Party: Tom Jaksic, W. Hardy Hendren Professor of Surgery, Harvard Medical School, Boston Children’s Hospital Identifier: NCT01191177     History of Changes
Other Study ID Numbers: 09-02-0066
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tom Jaksic, Boston Children’s Hospital:
oral fish oil
Omega-3-acid supplementation

Additional relevant MeSH terms:
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Liver Diseases
Short Bowel Syndrome
Pathologic Processes
Digestive System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Postoperative Complications