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

Boston Children's Hospital

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Short Bowel Syndrome; Liver Disease

Treatments: Dietary Supplement: Corn oil; Drug: Lovaza (omega-3-acid ethyl ester)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01191177

09-02-0066

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 30 days to 21 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Lovaza group

Experimental group

Description:

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

Treatment:

Drug: Lovaza (omega-3-acid ethyl ester)

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Corn oil