Total Parenteral Nutrition-Associated Liver Disease

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, January 2002

First Received: February 26, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00031135

Purpose

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.

Condition	Intervention	Phase
Liver Diseases	Drug: Choline Chloride	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title:	Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases

Drug Information available for: Choline Choline chloride Chlorides Choline dihydrogen citrate Choline bitartrate Choline salicylate

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	48
Study Start Date:	September 2001
Estimated Study Completion Date:	August 2004

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.

Eligibility

Ages Eligible for Study:	21 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031135

Locations

United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Alan L Buchman, M.D., MSPH 312-695-4514 A-BUCHMAN@NORTHWESTERN.EDU

Sponsors and Collaborators

FDA Office of Orphan Products Development

More Information

No publications provided

Study ID Numbers:	FD-R-1994-01, FD-R-001994-01
Study First Received:	February 26, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00031135 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Parenteral Nutrition, Total
Lipotropic Agents
Choline

Additional relevant MeSH terms:

Antimetabolites
Nootropic Agents
Lipotropic Agents
Choline
Liver Diseases
Digestive System Diseases

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Gastrointestinal Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009