Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis

Cystic Fibrosis Liver Disease Clinical Trial

Official title:

Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312140
• Other study ID #: Phos-CF II V1.2
• Status: Completed
• Phase: N/A
• First received: October 4, 2017
• Last updated: November 29, 2017
• Start date: November 6, 2014
• Est. completion date: February 8, 2017

Study information

• Verified date: October 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 measured before and after the intervention phase. Hypothesis of the study is, that supplying choline augments the secretion of phosphatidyl choline and lipoprotein (VLDL) from the liver and therefore results in a measurable reduction of the triglyceride storage of the liver.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 8, 2017
• Est. primary completion date: April 24, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis Liver Disease
• Fibrosis
• Liver Diseases

Intervention

Drug:
• Choline Chloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of D9-Methyl-Choline Kinetic	The substitution of choline as a food supplement will augment the phosphatidylcholine and lipoprotein (VLDL) secretion of the liver into the blood and will therefore result in a reduction of the triglyceride retention in the liver	3 months
Secondary	Lipid storage of the liver	Comparison of steatosis of the liver (measured by magnetic resonance spectroscopy or sonography) before to after the choline substitution	3 months
Secondary	Augmentation of creatinine concentration within the calf muscle	Augmentation of creatine concentration within the calf muscle due to the choline substitution measured by magnetic resonance spectroscopy	3 months
Secondary	FVC	Comparison of FVC before to after the choline substitution	3 months
Secondary	FEV1	Comparison of FEV1 before to after the choline substitution	3 months
Secondary	MEF25	Comparison of MEF25 before to after the choline substitution	3 months
Secondary	MMEF	Comparison of MMEF before to after the choline substitution	3 months