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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Harvard University
GlaxoSmithKline
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01191177
First received: August 27, 2010
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Liver Disease
Short Bowel Syndrome
Dietary Supplement: Lovaza (omega-3-acid ethyl ester)
Dietary Supplement: corn oil
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Normalization of ALT [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: unknown ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lovaza group
Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day
Dietary Supplement: 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
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
supplied as 1gram transparent soft gelatin capsules filled with yellow oil, dosage is 1gram per kilogram of body weight per day, not exceeding 4gram a day

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191177

Contacts
Contact: Tom Jaksic, MD, PhD 617 355 9600 tom.jaksic@childrens.harvard.edu
Contact: KuangHorng(Jamie) Kang, MD 617 919 2969 kuanghorng.kang@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Tom Jaksic, MD, PhD    617-355-9600    tom.jaksic@childrens.harvard.edu   
Contact: KuangHorng(Jamie) Kang, MD    617 919 2969    kuanghorng.kang@childrens.harvard.edu   
Principal Investigator: Tom Jaksic, MD, PhD         
Sponsors and Collaborators
Children's Hospital Boston
Harvard University
GlaxoSmithKline
Investigators
Principal Investigator: Tom Jaksic, MD, PhD Children's Hopsital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01191177     History of Changes
Other Study ID Numbers: 09-02-0066
Study First Received: August 27, 2010
Last Updated: November 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Boston:
oral fish oil
Lovaza
Omega-3-acid supplementation
Faster normalization of ALT with oral fish oil
Faster normalization of liver function test with oral fish oil
Increased growth with oral fish oil

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

ClinicalTrials.gov processed this record on September 18, 2014