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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 16 December 2017
Main ID:  NCT03312140
Date of registration: 04/10/2017
Prospective Registration: No
Primary sponsor: University Hospital Tuebingen
Public title: Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis
Scientific title: Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis
Date of first enrolment: November 6, 2014
Target sample size: 10
Recruitment status: Completed
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Name:     Joachim Riethmüller, PD
Affiliation:  Klinik für Kinder- und Jugendmedizin Tübingen
Key inclusion & exclusion 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

- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Male
Health Condition(s) or Problem(s) studied
Cystic Fibrosis Liver Disease
Drug: Choline Chloride
Primary Outcome(s)
Measurement of D9-Methyl-Choline Kinetic [Time Frame: 3 months]
Secondary Outcome(s)
Augmentation of creatinine concentration within the calf muscle [Time Frame: 3 months]
FEV1 [Time Frame: 3 months]
FVC [Time Frame: 3 months]
Lipid storage of the liver [Time Frame: 3 months]
MEF25 [Time Frame: 3 months]
MMEF [Time Frame: 3 months]
Secondary ID(s)
Phos-CF II V1.2
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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