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Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition



Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition

For Condition: Fatty Liver
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of Texas
Synopsis: OBJECTIVES: I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients receive either daily choline chloride in their total parenteral nutrition (TPN) solution or their usual TPN. The TPN is given intravenously over a 12 hour period beginning at approximately 9 PM nightly. Therapy continues for 24 weeks. Adjustments in the daily dose of choline provided may be required based on plasma free choline levels and patient tolerance. Additionally, all patients record the type and amount of their food intake on a daily basis. Patients are followed every 2 weeks during the first 6 weeks, then every 4 weeks beginning with week 12 for the remainder of the 24 weeks, and then again at week 34.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 16 Years/74 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Receiving nightly total parenteral nutrition (TPN) for greater than 70% of nutritional needs for a minimum of 8 weeks prior to study entry; Receiving no greater than 38 kcal/kg/day/ideal body weight; Receiving lipid emulsion as part of TPN regimen Expected to require TPN for at least 34 weeks after study entry Hepatic steatosis documented by prestudy CT scan Consistent daily amount of intravenous amino acids, dextrose, or lipid received for 3 weeks prior to study entry --Prior/Concurrent Therapy-- No concurrent cholinergic medications --Patient Characteristics-- Hepatic: Albumin at least 3.5 g/dL; No hepatic failure; PT no greater than 2 times upper limit of normal Renal: No renal failure requiring hemo- or peritoneal dialysis Other: No AIDS; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment: 15

Location and Contact Information:

Overall Study Official:
AlanBuchman,  Study Chair,  University of Texas


Additional Information:
Study ID Numbers:  199/13360;  UT-H-HSC-MS-97-018,BCM-FDR001118
Study Start Date: November 1997
Record last reviewed: March 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004697

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