Examination of the Lipid Metabolism of the Liver After Ch... | NCT03312140

Studies
Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis

NCT03312140

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Nov 30, 2017Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Cystic Fibrosis Liver Disease

Interventions

Choline Chloride

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2014Actual

Primary Completion Date

Apr 24, 2016Actual

Completion Date

Feb 8, 2017Actual

First Submitted Date

Oct 4, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2017

Last Update Posted Date

Nov 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pilot study to investigate the effect of choline chloride in cystic fibrosis patients with liver steatosis by comparing their status before and after the intervention

Detailed Description

Within this single arm pilot study patients with cystic fibrosis and liver steatosis receive choline chloride (2x0.5 gram three times a day) as a food supply for 88 days. D9-choline metabolism is measured before and after the intervention phase. Hypothesis of the study is, that supplying choline augments the secretion of phosphatidyl choline and lipoprotein (VLDL) from the liver and therefore results in a measurable reduction of the triglyceride storage of the liver.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Choline Chloride	Other	Patients receive choline chloride (1g Choline) three times a day for 12.6 weeks as a food supply	Drug: Choline Chloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Choline Chloride	Drug		Choline Chloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of D9-Methyl-Choline Kinetic	The substitution of choline as a food supplement will augment the phosphatidylcholine and lipoprotein (VLDL) secretion of the liver into the blood and will therefore result in a reduction of the triglyceride retention in the liver	3 months

Secondary Outcomes

Measure	Description	Time Frame
Lipid storage of the liver	Comparison of steatosis of the liver (measured by magnetic resonance spectroscopy or sonography) before to after the choline substitution	3 months
Augmentation of creatinine concentration within the calf muscle

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
male
Cystic fibrosis is verified
pancreatic insufficiency
Decline of plasma phosphatidylcholine and steatosis of the liver
informed consent is given

Exclusion Criteria:

cirrhosis of the liver
Hyperreactivity to choline containing food
allergic bronchopulmonary aspergillosis or other acute exacerbations of pulmonary infections
FEV1 < 40%
smoker
chronic alcohol consume
clinically relevant diseases (for example thyroid dysfunction, disturbance of lipid metabolism, renal diseases, significant left or right ventricular functional restriction) which will change the lipid metabolism of the liver
Implants or other reasons which make magnetic resonance examinations impossible

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Riethmüller, PD	Klinik für Kinder- und Jugendmedizin Tübingen	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002794	Choline

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided