A Trial of Taurine Supplementation in Parenteral Nutrition 1

NCT00135044 | Unknown

• 1 other identifier: Taurine05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholestasis

Keywords

taurine; intestinal failure; HPN; hepatobiliary complications; chronic intestinal failure (CIF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

intravenous taurine in nutritional supplement PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead
• Fresenius AG: collaborator

Study Sites (1)

North West London NHS Trust - St Mark's Hospital

Harrow, London, Middlesex, HA1 3Uj, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cholestasis; Intestinal Failure

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Simon Gabe, MD

  North West London NHS Trust - St Mark's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Culkin

CONTACT

alison.culkin@nwlh.nhs.uk

Simon Gabe, MD

CONTACT

simon.gabe@nwlh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2005
• First Posted: August 25, 2005
• Study Start: June 1, 2005
• Last Updated: September 24, 2007

Record last verified: 2007-09

Locations

GB (1)