Total Parenteral Nutrition-Associated Liver Disease

Stopped early · Phase 2

Conditions studied: Liver Diseases

In brief

This is a study to determine whether choline, when added to total parenteral nutrition (TPN), can help prevent the development of hepatic steatosis, a liver disease, in patients on TPN.

Key facts

Study ID

NCT00031135

Run by

Northwestern University

People needed

48

Starts

2001-09-01

Expected to finish

2005-09-01

Last updated by the study team

2015-03-25

Who can join

Age: 21 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Underlying pathology may include, but is not limited to: short bowel syndrome, chronic pancreatitis, pancreatic pseudocysts, pseudo-obstruction, enterocutaneous fistula, entero-enteric fistula, or malabsorption syndrome.
• Requirement for TPN to supply greater than 85 percent of nutritional needs for at least 16 weeks.

You may not qualify if…

• Not receiving lipid emulsion with TPN regimen
• Albumin less than 2.5 g/L
• Renal failure requiring hemo- or peritoneal dialysis
• Hepatic failure (PT greater than 2 times control)
• Diabetes
• Hepatitis C
• AIDS
• Concurrent hospitalization for organ transplantation or rejection treatment
• Concurrent cholinergic medication
• Positive pregnancy test
• Refusal to use an acceptable method of birth control
• Ethanol abuse
• More than 40 kcal/kg/day ideal body weight
• Obesity with ensuing weight loss
• Use of IV tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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