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

Not Applicable

Completed

• Conditions: Fatty Liver

• Registration Number: NCT00004697
• Lead Sponsor: University of Texas

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 1997-11
• Status Verified: 1999-03
• Study Completion: 1999-03
• Study First Submitted: 2000-02-24
• Study First Submitted QC: 2000-02-24
• Study First Posted: 2000-02-25
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified