|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
FDA Office of Orphan Products Development |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00031135 |
Purpose
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 | Intervention | Phase |
|
Liver Diseases |
Drug: Choline Chloride |
Phase II |
| MedlinePlus related topics: | Liver Diseases |
| Drug Information available for: | Chlorides Choline Choline bitartrate Choline chloride Choline dihydrogen citrate Choline salicylate |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study |
| Official Title: | Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial |
| Estimated Enrollment: | 48 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | August 2004 |
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.
Eligibility
| Ages Eligible for Study: | 21 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, Illinois | |||||
| Northwestern University | Recruiting | ||||
| Chicago, Illinois, United States, 60611 | |||||
| Contact: Alan L Buchman, M.D., MSPH 312-695-4514 A-BUCHMAN@NORTHWESTERN.EDU | |||||
More Information
| Study ID Numbers: | FD-R-1994-01, FD-R-001994-01 |
| First Received: | February 26, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00031135 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|