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Total Parenteral Nutrition-Associated Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00031135
Recruitment Status : Terminated
First Posted : February 27, 2002
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

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.

Condition or disease Intervention/treatment Phase
Liver Diseases Drug: Choline Chloride Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial
Study Start Date : September 2001
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031135

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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ClinicalTrials.gov Identifier: NCT00031135    
Other Study ID Numbers: FD-R-1994-01
First Posted: February 27, 2002    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: January 2002
Keywords provided by FDA Office of Orphan Products Development:
Parenteral Nutrition, Total
Lipotropic Agents
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents