Fatty Liver Clinical Trial
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.
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.
Completion date provided represents the completion date of the grant per OOPD records
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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