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| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 26, 2002 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | September 2001 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00031135 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Total Parenteral Nutrition-Associated Liver Disease |
| Official Title ICMJE | Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial |
| 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. |
| 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. |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study |
| Condition ICMJE | Liver Diseases |
| Intervention ICMJE | Drug: Choline Chloride |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Enrollment ICMJE | 48 |
| Completion Date | August 2004 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
|
| Gender | Both |
| Ages | 21 Years to 74 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00031135 |
| Responsible Party | |
| Study ID Numbers ICMJE | FD-R-1994-01, FD-R-001994-01 |
| Study Sponsor ICMJE | FDA Office of Orphan Products Development |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | FDA Office of Orphan Products Development |
| Verification Date | January 2002 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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