Fatty LiverNCT00004697
Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
A study testing choline chloride in people with Fatty Liver, run by University of Texas.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 74 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- choline chloride
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 1997to Mar 1999
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
OBJECTIVES:
- Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.
Read the 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
- Conditions
- Fatty Liver
- Being tested
- choline chloride
- Keywords
- gastrointestinal disorders, hepatic steatosis, rare disease
- Medical subject headings
- Fatty Liver, Gastrointestinal Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choline chlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startNov 1997
- Study completionMar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- University of Texas
- Sponsor type
- University, hospital or other
- Investigators
- Alan Lewis Buchman, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004697
- Sponsor's protocol ID
- 199/13360
- Other IDs
- UT-H-HSC-MS-97-018, BCM-FDR001118
- Status last verified
- Mar 1999
- First submitted
- 24 Feb 2000
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT00004697
- Acronym / sponsor ID
- 199/13360
- Conditions
- Fatty Liver
- Keywords
- gastrointestinal disorders, hepatic steatosis, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- University of TexasUniversity, hospital or other
- Study start
- Nov 1997
- Study completion
- Mar 1999
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| choline chloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Lewis Buchman study chair
University of Texas
Questions about this trial
What is this clinical trial studying?
A study testing choline chloride in people with Fatty Liver, run by University of Texas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.