Total Parenteral Nutrition-Associated Liver Disease

Phase 2

Terminated

• Conditions: Liver Diseases

• Registration Number: NCT00031135
• Lead Sponsor: Northwestern University

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2001-09
• Status Verified: 2002-01
• Study First Submitted: 2002-02-26
• Study First Submitted QC: 2002-02-26
• Study First Posted: 2002-02-27
• Study Completion: 2005-09
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States