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

NCT ID: NCT03312140

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-06

Study Completion Date

2017-02-08

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study to evolve the effect ot the treatment by comparing data before and after the treatment within the same patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Choline Chloride

Patients receive choline chloride (1g Choline) three times a day for 12.6 weeks as a food supply

Group Type OTHER

Choline Chloride

Intervention Type DRUG

Interventions

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Choline Chloride

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joachim Riethmüller, PD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Kinder- und Jugendmedizin Tübingen

Other Identifiers

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Phos-CF II V1.2

Identifier Type: -

Identifier Source: org_study_id