A Trial of Taurine Supplementation in Parenteral Nutrition 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by North West London Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fresenius AG
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00135044
First received: August 24, 2005
Last updated: September 21, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention
Cholestasis
Procedure: intravenous taurine in nutritional supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by North West London Hospitals NHS Trust:

Primary Outcome Measures:
  • Whether the inclusion of 1g of intravenous taurine as part of the nitrogen source of parenteral nutrition reduces parenteral nutrition associated cholestatic liver disease

Secondary Outcome Measures:
  • Can additional taurine affect septic complications occuring in patients receiving parenteral nutrition
  • Can additional taurine improve dendritic cell function
  • Do patients on home parenteral nutrition have low levels of taurine
  • Does giving additional taurine cause an increase in levels of taurine
  • Does giving additional taurine cause an increase in urinary taurine excretion

Estimated Enrollment: 24
Study Start Date: June 2005
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 41.5% 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135044

Contacts
Contact: Alison Culkin alison.culkin@nwlh.nhs.uk
Contact: Simon Gabe, MD simon.gabe@nwlh.nhs.uk

Locations
United Kingdom
North West London NHS Trust - St Mark's Hospital Recruiting
Harrow, London, Middlesex, United Kingdom, HA1 3Uj
Contact: Alan Warnes, PhD       alan.warnes@nwlh.nhs.uk   
Contact: Iva Hauptmannova       iva.hauptmannova@nwlh.nhs.uk   
Sponsors and Collaborators
North West London Hospitals NHS Trust
Fresenius AG
Investigators
Principal Investigator: Simon Gabe, MD North West London NHS Trust - St Mark's Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00135044     History of Changes
Other Study ID Numbers: Taurine05
Study First Received: August 24, 2005
Last Updated: September 21, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by North West London Hospitals NHS Trust:
taurine
intestinal failure
HPN
hepatobiliary complications
chronic intestinal failure (CIF)

Additional relevant MeSH terms:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 01, 2014