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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 1999 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Texas
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004697
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: March 1999
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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
FDA Office of Orphan Products Development
University of Texas
Investigators
Study Chair: Alan Lewis Buchman University of Texas
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013