Total Parenteral Nutrition-Associated Liver Disease

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Choline Chloride

About this trial

This is an interventional prevention trial for Liver Diseases focused on measuring Parenteral Nutrition, Total, Lipotropic Agents, Choline

Eligibility Criteria

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

Inclusion criteria: Underlying pathology may include, but is not limited to: short bowel syndrome, chronic pancreatitis, pancreatic pseudocysts, pseudo-obstruction, enterocutaneous fistula, entero-enteric fistula, or malabsorption syndrome. Requirement for TPN to supply greater than 85 percent of nutritional needs for at least 16 weeks. Exclusion criteria: Not receiving lipid emulsion with TPN regimen Albumin less than 2.5 g/L Renal failure requiring hemo- or peritoneal dialysis Hepatic failure (PT greater than 2 times control) Diabetes Hepatitis C AIDS Concurrent hospitalization for organ transplantation or rejection treatment Concurrent cholinergic medication Positive pregnancy test Refusal to use an acceptable method of birth control Ethanol abuse More than 40 kcal/kg/day ideal body weight Obesity with ensuing weight loss Use of IV tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone

Sites / Locations

Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00031135

First Posted

February 26, 2002

Last Updated

March 24, 2015

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT00031135

Brief Title

Total Parenteral Nutrition-Associated Liver Disease

Official Title

Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2002

Overall Recruitment Status

Terminated

Study Start Date

September 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Northwestern University

4. Oversight

5. Study Description

Brief Summary

This is a study to determine whether choline, when added to total parenteral nutrition (TPN), can help prevent the development of hepatic steatosis, a liver disease, in patients on TPN.

Detailed Description

Choline deficiency-induced hepatic steatosis occurs in patients that require long-term TPN and may progress to significant hepatic disease and death. Initial studies indicate choline-supplemented TPN may reverse TPN-associated hepatic steatosis. Choline chloride or placebo will be added to each patient's TPN for 16 weeks by the hospital or pharmacy providing their usual TPN. Patients will receive their TPN in the hospital until they are medically stable for discharge. If patients are discharged before study completion, the pharmacy will deliver the TPN supply to them. Evaluation of hepatic steatosis is done by CT scans and blood analyses. Blood will be drawn on a biweekly basis during the first 4 weeks and at Week 8, 12, 16 or withdrawal. CT scans will be done at Week 4, 8, 16, or withdrawal. 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

Liver Diseases

Keywords

Parenteral Nutrition, Total, Lipotropic Agents, Choline

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Masking

Double

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Choline Chloride

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria: Underlying pathology may include, but is not limited to: short bowel syndrome, chronic pancreatitis, pancreatic pseudocysts, pseudo-obstruction, enterocutaneous fistula, entero-enteric fistula, or malabsorption syndrome. Requirement for TPN to supply greater than 85 percent of nutritional needs for at least 16 weeks. Exclusion criteria: Not receiving lipid emulsion with TPN regimen Albumin less than 2.5 g/L Renal failure requiring hemo- or peritoneal dialysis Hepatic failure (PT greater than 2 times control) Diabetes Hepatitis C AIDS Concurrent hospitalization for organ transplantation or rejection treatment Concurrent cholinergic medication Positive pregnancy test Refusal to use an acceptable method of birth control Ethanol abuse More than 40 kcal/kg/day ideal body weight Obesity with ensuing weight loss Use of IV tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Liver Diseases

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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