DRKS00032870
Recruiting
未知
Radiological and biochemical effects in children, adolescents and young adults under supplementation with the dietary supplement choline on cystic fibrosis-associated liver disease. - SHIELD (Substitution in choline defcient CFALD)
niversitätsklinik Tübingen0 sites50 target enrollmentOctober 16, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cystic fibrosis associated liver disease
- Sponsor
- niversitätsklinik Tübingen
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 6 years and older up to the age of 25 years with a diagnosis of cystic fibrosis.
- •\- Detection of the CFTR genotype
- •\- Exocrine pancreatic insufficiency
- •\- Presence of CF\-associated hepatopathy (steatosis, elevation of hepatocellular enzymes, liver parenchymal changes in the sense of fibrosis).
- •\- Laboratory evidence of at least once decreased plasma concentration of choline (\<8\.1µmol/l) with recommendation for supplementation with a choline\-containing food supplement.
- •\- Written informed consent and agreement to the data protection declaration
Exclusion Criteria
- •\- Lack of informed consent
- •\- Patients who want to implement the recommendation for choline supplementation in any case, i.e., cannot be randomized
- •\- Chronic alcohol consumption
- •\- Concomitant liver disease apart from CFALD, such as infectious or congenital or autoimmune liver disease, Meulengracht disease, or Wilson disease
- •\- Irreversible cirrhotic liver remodeling
- •\- Patients in whom there is no indication for blood sampling outside of the trial
- •\- Critically ill patients who cannot be expected to undergo additional sonography or MRI examinations or who have a contraindication to MRI examinations
- •\- Patients who require sedation/anesthesia to undergo sonography or MRI examination.
- •\- Participation in another interventional study or planned start of another interventional study within the study period planned here, for example with a disease modifier (modulator).
Outcomes
Primary Outcomes
Not specified
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