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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: FDA Office of Orphan Products Development
University of Texas
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00004697
  Purpose

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.


Condition Intervention
Fatty Liver
Drug: choline chloride

Drug Information available for:   Chlorides    Choline    Choline bitartrate    Choline chloride    Choline dihydrogen citrate    Choline salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:   15
Study Start Date:   November 1997

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.

  Eligibility
Ages Eligible for Study:   16 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004697

Sponsors and Collaborators

Investigators
Study Chair:     Alan Lewis Buchman     University of Texas    
  More Information


Study ID Numbers:   199/13360, UT-H-HSC-MS-97-018, BCM-FDR001118
First Received:   February 24, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004697
Health Authority:   United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
gastrointestinal disorders  
hepatic steatosis  
rare disease  

Study placed in the following topic categories:
Choline
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rare Diseases
Fatty Liver

Additional relevant MeSH terms:
Antimetabolites
Nootropic Agents
Lipotropic Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Gastrointestinal Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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