World Health Organization site
Skip Navigation Links

Main
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.
Register: ClinicalTrials.gov
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
URL:  https://clinicaltrials.gov/show/NCT03312140
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Contacts
Name:     Joachim Riethmüller, PD
Address: 
Telephone:
Email:
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
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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male
Health Condition(s) or Problem(s) studied
Cystic Fibrosis Liver Disease
Intervention(s)
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
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history