Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135044
Status:
UNKNOWN
Last Update Posted:
2007-09-24
First Post:
2005-08-24
Brief Title:
A Trial of Taurine Supplementation in Parenteral Nutrition 1
Sponsor:
London North West Healthcare NHS Trust
Organization:
London North West Healthcare NHS Trust
Study Overview
Official Title:
A Randomised Double Blind Controlled Crossover Trial of Intravenous Taurine Supplementation in Parenteral Nutrition as an Effective Treatment for Reducing Hepatobiliary Complications in Chronic Intestinal Failure
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
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:
The purpose of this study is to investigate whether the inclusion of 1g of intravenous taurine as part of the nitrogen source of parenteral nutrition reduces parenteral nutrition associated cholestatic liver disease a common side effect of parenteral nutrition
Detailed Description:
Parenteral nutrition associated cholestasis PNAC is one of the main causes of death during long-term home parenteral nutrition HPN In one study 65 of patients on NPN developed PNAC after a median of 6 months and 415 developed HPN associated liver disease after a median of 17 months It is thought that this condition develops due to changes in bile acid conjugation Bile acids are conjugated with either taurine or glycine before their secretion in bile Man obtains taurine mostly from the diet and hepatic taurine conjugation of bile acids accounts for 30-40 of the total bile acid pool Taurine-conjugated bile acids are more water soluble and less toxic than glycine-conjugated bile acids The ratio of glycine to taurine conjugated bile acids appears to be important and studies in rats have found that the bile acid sulfolithocholate which is conjugated with glycine was cholestatic while the taurine conjugated was not Further studies in guinea pigs have shown that dietary taurine supplements prevent the cholestasis induced by sulfolithocholate by increasing the percentage of taurine conjugated bile acids Patients on intravenous nutrition with intestinal failure may not re-absorb bile acids normally and may have increased losses of taurine conjugated of bile acids They have also been found to have low levels of taurine It is thought that chronic taurine deficiency by altering the pattern of conjugation of bile acids may predispose to cholestasis and ultimately severe hepatic dysfunction In a study of hepatobiliary surgical patients given dietary taurine post operatively there was enhanced conjugation and secretion of bile acids Bilirubin levels fell during taurine supplementation compared to patients not receiving taurine although this was not significant We are going to investigate if parenteral taurine supplementation is beneficial in our patients experiencing this condition
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