Status:
COMPLETED
Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Cystic Fibrosis Liver Disease
Eligibility:
MALE
18+ years
Phase:
NA
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 meas...
Eligibility Criteria
Inclusion
- Age \> 18 years
- male
- Cystic fibrosis is verified
- pancreatic insufficiency
- Decline of plasma phosphatidylcholine and steatosis of the liver
- informed consent is given
Exclusion
- 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
Key Trial Info
Start Date :
November 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03312140
Start Date
November 6 2014
End Date
February 8 2017
Last Update
November 30 2017
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