Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004697
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
Sponsor:
University of Texas
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition
I Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition
Detailed Description:
PROTOCOL OUTLINE
This is a randomized double blind placebo controlled study
Patients receive either daily choline chloride in their total parenteral nutrition TPN solution or their usual TPN The TPN is given intravenously over a 12 hour period beginning at approximately 9 PM nightly Therapy continues for 24 weeks Adjustments in the daily dose of choline provided may be required based on plasma free choline levels and patient tolerance Additionally all patients record the type and amount of their food intake on a daily basis
Patients are followed every 2 weeks during the first 6 weeks then every 4 weeks beginning with week 12 for the remainder of the 24 weeks and then again at week 34
Completion date provided represents the completion date of the grant per OOPD records
This is a randomized double blind placebo controlled study
Patients receive either daily choline chloride in their total parenteral nutrition TPN solution or their usual TPN The TPN is given intravenously over a 12 hour period beginning at approximately 9 PM nightly Therapy continues for 24 weeks Adjustments in the daily dose of choline provided may be required based on plasma free choline levels and patient tolerance Additionally all patients record the type and amount of their food intake on a daily basis
Patients are followed every 2 weeks during the first 6 weeks then every 4 weeks beginning with week 12 for the remainder of the 24 weeks and then again at week 34
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UT-H-HSC-MS-97-018 | None | None | None |
| BCM-FDR001118 | None | None | None |