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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Estimated Enrollment: | 15 |
| Study Start Date: | November 1997 |
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 |
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 More Information
| Study ID Numbers: | 199/13360, UT-H-HSC-MS-97-018, BCM-FDR001118 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004697 History of Changes |
| Health Authority: | United States: Federal Government |
|
gastrointestinal disorders hepatic steatosis rare disease |
|
Antimetabolites Nootropic Agents Choline Liver Diseases Digestive System Diseases |
Gastrointestinal Diseases Antilipemic Agents Rare Diseases Fatty Liver |
|
Antimetabolites Lipotropic Agents Nootropic Agents Liver Diseases Choline Molecular Mechanisms of Pharmacological Action Antilipemic Agents |
Gastrointestinal Agents Fatty Liver Pharmacologic Actions Digestive System Diseases Therapeutic Uses Central Nervous System Agents |
