Status:
UNKNOWN
A Trial of Taurine Supplementation in Parenteral Nutrition 1
Lead Sponsor:
London North West Healthcare NHS Trust
Collaborating Sponsors:
Fresenius AG
Conditions:
Cholestasis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 cholestati...
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 media...
Eligibility Criteria
Inclusion
- Chronic intestinal failure (CIF) patients on long term home parenteral nutrition, under the care of the Nutrition and Intestinal Failure Clinic at St Mark's, who have PNAC.
- Must be over 18
- On HPN for 6 months and stable
- Life expectancy of over 12 months
- HPN should provide \> 75-80% of estimated nutritional requirements
- Should be on HPN for 5 or more days per week
Exclusion
- No consent.
- Pregnancy/lactation.
- Planned surgery.
- Renal failure.
- Hepatitic failure, ultrasound proven fibrosis or cirrhosis, poorly controlled diabetes, hepatitis B or C, autoimmune liver disease, receiving \> 40 kcal/kg/day from HPN, current sepsis, co-existing surgical complications such as intestinal obstruction, hepatotoxic drugs, primary liver cancer or metastases or any other cause for pre and post hepatic jaundice.
- Inability to adhere to the protocol.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00135044
Start Date
June 1 2005
Last Update
September 24 2007
Active Locations (1)
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1
North West London NHS Trust - St Mark's Hospital
Harrow, London, Middlesex, United Kingdom, HA1 3Uj