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

Primary Purpose

Liver Disease, Short Bowel Syndrome

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lovaza (omega-3-acid ethyl ester)
Corn oil
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Disease focused on measuring oral fish oil, Lovaza, Omega-3-acid supplementation

Eligibility Criteria

30 Days - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lovaza group

Placebo group

Arm Description

Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day

Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day

Outcomes

Primary Outcome Measures

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

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).

Full Information

First Posted
August 27, 2010
Last Updated
June 20, 2017
Sponsor
Boston Children's Hospital
Collaborators
Harvard University, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01191177
Brief Title
Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease
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 Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no subjects recruited
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Harvard University, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease, Short Bowel Syndrome
Keywords
oral fish oil, Lovaza, Omega-3-acid supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lovaza group
Arm Type
Experimental
Arm Description
Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day
Intervention Type
Drug
Intervention Name(s)
Lovaza (omega-3-acid ethyl ester)
Other Intervention Name(s)
fish oil
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn oil
Intervention Description
1 gram per kilogram body weight per day, not exceeding 4 grams
Primary Outcome Measure Information:
Title
Normalization of ALT
Description
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 Measure Information:
Title
Normalization other liver function tests and inflammatory status
Description
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Jaksic, MD, PhD
Organizational Affiliation
Children's Hopsital Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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