Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants

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Disease Information

Descriptive Information
Brief Title † Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
Official Title †
Brief Summary OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the nontreatment arm. II. Determine the significance of lower birth weight and longer duration of total parenteral nutrition (TPN) on increasing risk of TPN associated cholestasis and increasing benefit from TUDCA therapy. III. Determine whether TUDCA therapy leads to significant reduction in the appearance of biliary tract sludge and/or stone formation in these infants. IV. Determine whether TUDCA therapy leads to reduced urinary excretion of potentially hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration of TPN.
Detailed Description PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by birth weight. Patients are randomized in pairs by birth weight to receive either a placebo in arm I or tauroursodeoxycholic acid (TUDCA) in arm II. TUDCA is administered by mouth, nasogastric tube, or gastrostomy tube twice daily. After 2 weeks of therapy, a bile sample is obtained via a duodenal tube. An ultrasound examination of the liver and biliary tract is performed after 2 weeks and every 3 weeks thereafter until discontinuation of therapy or until presence of biliary tract sludge is noted on 2 consecutive examinations. Completion date provided represents the completion date of the grant per OOPD records
Study Phase N/A
Study Type † Interventional
Study Design † Allocation: Randomized, Primary Purpose: Treatment
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Cholestasis
Intervention † Drugtauroursodeoxycholic acid
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 50
Start Date † June 1998
Completion Date March 2002
Primary Completion Date
Eligibility Criteria † PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Hospitalized infants who are anticipated to require total parenteral nutrition for greater than 2 weeks and have: Major gastrointestinal anomalies (gastroschisis, ruptured omphalocele) OR Resection (necrotizing enterocolitis, volvulus) - No evidence of biliary tract abnormalities - No evidence of other forms of cholestatic liver disease --Patient Characteristics-- - Renal: No life threatening renal disease - Cardiovascular: No life threatening cardiovascular disease - Other: No multiple congenital abnormalities
Gender Both
Ages N/A - 20 Days
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00004410
Organization ID 199/13299
Secondary IDs †† CHMC-C-95-9-9, CHMC-C-CRC-473, CHMC-C-FDR001277
Responsible Party
Study Sponsor † Children's Hospital Medical Center, Cincinnati
Collaborators ††
Investigators † Study Chair: James Heubi, Children's Hospital Medical Center, Cincinnati
Information Provided By
Verification Date August 1998
First Received Date † October 18, 1999
Last Updated Date March 24, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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