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

NCT01191177 | Withdrawn Phase 1 DMC

• 1 other identifier: 09-02-0066
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Disease; Short Bowel Syndrome

Keywords

oral fish oil; Lovaza; Omega-3-acid supplementation

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Normalization other liver function tests and inflammatory status

Study Arms (2)

Lovaza group

EXPERIMENTAL

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)

Placebo group

PLACEBO COMPARATOR

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

Interventions

Lovaza (omega-3-acid ethyl ester) DRUG

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

Also known as: fish oil

Lovaza group

Corn oil DIETARY_SUPPLEMENT

1 gram per kilogram body weight per day, not exceeding 4 grams

Placebo group

Eligibility Criteria

• Age: 30 Days - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Harvard University: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Liver Diseases; Short Bowel Syndrome

Interventions

Omacor; Fish Oils; Corn Oil

Condition Hierarchy (Ancestors)

Digestive System Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tom Jaksic, MD, PhD

  Children's Hopsital Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: W. Hardy Hendren Professor of Surgery, Harvard Medical School

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)