Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367198
Status:
TERMINATED
Last Update Posted:
2011-07-12
First Post:
2006-08-18
Brief Title:
Protein Supplementation in Dialysis Patients
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Protein Supplementation in Dialysis Patients
Status:
TERMINATED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The mortality rate in chronic hemodialysis CHD patients remains excessively high and approaches 21 per year Among the many factors that adversely affects patient outcome is uremic malnutrition a unique form of deranged nutritional status It is associated with increased hospitalization and death risk in CHD patients Several measures have been identified to prevent uremic malnutrition in CHD patients including efforts to optimize dialysis regimen and dietary protein and energy intake A large number of CHD patients suffer from uremic malnutrition in spite of these aggressive measures The inevitable protein catabolic effects of the hemodialysis procedure are important factors leading to increased prevalence of uremic malnutrition Preliminary data suggest that oral nutritional supplementation administered during the hemodialysis procedure counteracts these protein catabolic effects and leads to net protein anabolism in the acute setting In this proposal we hypothesize that Pro-Stat a high nitrogen enzyme-hydrolyzed tryptophan-fortified collagen protein supplement will reverse the net protein catabolism observed during hemodialysis procedure
Detailed Description:
None
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