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	Treatment or Intervention	Phase
Liver Diseases	Drug: Choline Chloride	Phase II

Further Study Details: 

Expected Total Enrollment:  48

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.

Ages Eligible for Study:  21 Years   -   74 Years,  Genders Eligible for Study:  Both

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

Illinois
      Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting

Study ID Numbers:  FD-R-1994-01; FD-R-001994-01
Record last reviewed:  January 2002
Last Updated:  October 13, 2004
Record first received:  February 26, 2002
ClinicalTrials.gov Identifier:  NCT00031135
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08