Total Parenteral Nutrition-Associated Liver Disease

Liver Diseases Clinical Trial

Official title:

Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00031135
• Other study ID #: FD-R-1994-01
• Secondary ID: FD-R-001994-01
• Status: Terminated
• Phase: Phase 2
• First received: February 26, 2002
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: September 2005

Study information

• Verified date: January 2002
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Choline deficiency-induced hepatic steatosis occurs in patients that require long-term TPN and may progress to significant hepatic disease and death. Initial studies indicate choline-supplemented TPN may reverse TPN-associated hepatic steatosis.

Choline chloride or placebo will be added to each patient's TPN for 16 weeks by the hospital or pharmacy providing their usual TPN. Patients will receive their TPN in the hospital until they are medically stable for discharge. If patients are discharged before study completion, the pharmacy will deliver the TPN supply to them. Evaluation of hepatic steatosis is done by CT scans and blood analyses. Blood will be drawn on a biweekly basis during the first 4 weeks and at Week 8, 12, 16 or withdrawal. CT scans will be done at Week 4, 8, 16, or withdrawal.

Completion date provided represents the completion date of the grant per OOPD records

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 74 Years

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Drug:
• Choline Chloride

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States,