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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004697

Enrollment

Registered

2000-02-25

Start date

1997-11-30

Completion date

1999-03-31

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

Keywords

gastrointestinal disorders, hepatic steatosis, rare disease

Brief summary

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.

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. Completion date provided represents the completion date of the grant per OOPD records

Interventions

DRUGcholine chloride

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 74 Years

Healthy volunteers

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026