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 个研究点目标入组 50 人开始时间: 2023年10月16日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•- 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).

发起方

niversitätsklinik Tübingen