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

February 24, 2000
June 23, 2005
November 1997
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Complete list of historical versions of study NCT00004697 on ClinicalTrials.gov Archive Site
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Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
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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.

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.

Interventional
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Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Fatty Liver
Drug: choline chloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
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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

Both
16 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004697
199/13360, UT-H-HSC-MS-97-018, BCM-FDR001118
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FDA Office of Orphan Products Development
University of Texas
Study Chair: Alan Lewis Buchman University of Texas
FDA Office of Orphan Products Development
March 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP