Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
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|ClinicalTrials.gov Identifier: NCT00004697|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.
|Condition or disease||Intervention/treatment|
|Fatty Liver||Drug: choline chloride|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Study Start Date :||November 1997|
|Estimated Study Completion Date :||March 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004697
|Study Chair:||Alan Lewis Buchman||University of Texas|