Total Parenteral Nutrition-Associated Liver Disease
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|ClinicalTrials.gov Identifier: NCT00031135|
Recruitment Status : Terminated
First Posted : February 27, 2002
Last Update Posted : March 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Liver Diseases||Drug: Choline Chloride||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Official Title:||Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial|
|Study Start Date :||September 2001|
|Study Completion Date :||September 2005|
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
|United States, Illinois|
|Chicago, Illinois, United States, 60611|