Fish Oil for Patients With Liver Disease Due to Parenteral Nutrition

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients who are not able to eat normally for a longer time require parenteral nutrition, i.e. they receive liquids and nutrients directly into their veins. This can have many long-term side effects, including liver problems. This study will examine whether a specific lipid emulsion containing fish oil can improve liver disease in patients on parenteral nutrition. The investigators will compare changes in bilirubin and liver enzymes after 3 months in 10 patients receiving standard lipid emulsion to 10 patients receiving standard lipids + a fish-oil containing emulsion. The investigators will also assess liver histology, the kind of fat, oxidative stress and gene expression in the liver at the beginning and after 6 months of fish-oil. The investigators also want to compare the baseline values from all 20 patients to 20 healthy controls. This will help to explain how fish oil may improve liver disease in patients on parenteral nutrition.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johane Allard
• Collaborators: ASPEN Rhoads Research Foundation; Foothills Medical Centre; Fresenius Kabi; Hamilton Health Sciences Corporation; St. Boniface General Hospital Research Centre; St. Boniface Hospital; St. Paul's Hospital, Canada; University of Alberta
• Treatments: Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• Clinically stable patients on home TPN with PNALD with persistently elevated bilirubin (>1.5 times > normal) for at least 3 months despite standard treatment with ursodeoxycholic acid (15-30 mg/kg or at least 500 mg/d orally), changes in TPN (reduction to 25 kcal/kg/TPN day with Intralipid 0.25 g/kg) , and antibiotics (Metronidazole 500 mg bid and Ciprofloxacin 500 mg bid)

• male or female,equal or over 18 years of age

• on stable TPN regimen equal or over 3 days/week

• on a stable drug regimen for equal or over 3 months prior to randomization, which will not changed for the study duration if these drugs are ursodeoxycholic acid given for PNALD or others affecting glucose and lipid metabolism

Exclusion Criteria:

• Not receiving lipid emulsion as part of TPN

• Allergy to fish, egg , soy, and peanuts

• Liver disease of other etiology (e.g. excessive alcohol intake >20g/d, viral hepatitis, auto-immune or drug-induced, hemochromatosis, alfa 1-antitrypsin deficiency, Wilson's disease)

• Complications of chronic liver disease, such as recurrent variceal bleeding, ascites, encephalopathy or any other reason contraindicating a liver biopsy

• Severe hemorrhagic disorders

• Sepsis - Inflammatory processes

• Taking medications that precipitate steatohepatitis (e.g. corticosteroids, methotrexate, or amiodarone)

• Pregnancy, lactation

• Fluid restriction - Omegaven is more dilute than Intralipid.