NCT00031135

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2002

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2002

First QC Date

February 26, 2002

Last Update Submit

March 24, 2015

Conditions

Liver Diseases

Keywords

Parenteral Nutrition, TotalLipotropic AgentsCholine

Interventions

Choline ChlorideDRUG

Eligibility Criteria

Age21 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Liver DiseasesHyperphagia

Interventions

Choline

Condition Hierarchy (Ancestors)

Digestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsOnium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2002

First Posted

February 27, 2002

Study Start

September 1, 2001

Study Completion

September 1, 2005

Last Updated

March 25, 2015

Record last verified: 2002-01

Locations

US(1)