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

Fatty Liver Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004697
• Other study ID #: 199/13360
• Secondary ID: UT-H-HSC-MS-97-0
• Status: Completed
• Phase: N/A
• First received: February 24, 2000
• Last updated: March 24, 2015
• Start date: November 1997
• Est. completion date: March 1999

Study information

• Verified date: March 1999
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver

Intervention

Drug:
• choline chloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas