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Total Parenteral Nutrition-Associated Liver Disease
This study is currently recruiting participants.
Study NCT00031135   Information provided by FDA Office of Orphan Products Development
First Received: February 26, 2002   Last Updated: June 23, 2005   History of Changes

February 26, 2002
June 23, 2005
September 2001
 
 
 
Complete list of historical versions of study NCT00031135 on ClinicalTrials.gov Archive Site
 
 
 
Total Parenteral Nutrition-Associated Liver Disease
Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial

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.

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.

Phase II
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Liver Diseases
Drug: Choline Chloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
48
August 2004
 

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
Both
21 Years to 74 Years
No
 
United States
 
NCT00031135
 
FD-R-1994-01, FD-R-001994-01
FDA Office of Orphan Products Development
 
 
FDA Office of Orphan Products Development
January 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP