Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||November 1997|
|Estimated Study Completion Date:||March 1999|
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.
Completion date provided represents the completion date of the grant per OOPD records
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004697
|Study Chair:||Alan Lewis Buchman||University of Texas|