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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

choline chloride

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring gastrointestinal disorders, hepatic steatosis, rare disease

Eligibility Criteria

16 Years - 74 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004697

First Posted

February 24, 2000

Last Updated

March 24, 2015

Sponsor

University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT00004697

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 1999

Overall Recruitment Status

Completed

Study Start Date

November 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 1999 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Texas

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatty Liver

Keywords

gastrointestinal disorders, hepatic steatosis, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

Double

Allocation

Randomized

Enrollment

15 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

choline chloride

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan Lewis Buchman

Organizational Affiliation

University of Texas

Official's Role

Study Chair

Fatty Liver

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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