Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031135
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
2002-02-26
Brief Title:
Total Parenteral Nutrition-Associated Liver Disease
Sponsor:
Northwestern University
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Prevention of TPN-Associated Hepatic Steatosis A Placebo Controlled Trial
Status:
TERMINATED
Status Verified Date:
2002-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
Choline chloride or placebo will be added to each patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-001994-01 | None | None | None |