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

NCT03312140 | Completed

• 1 other identifier: Phos-CF II V1.2
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cystic Fibrosis Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Lipid storage of the liver

  3 months

• Augmentation of creatinine concentration within the calf muscle

  3 months

• FVC

  3 months

• FEV1

  3 months

• MEF25

  3 months

Study Arms (1)

Choline Chloride

OTHER

Patients receive choline chloride (1g Choline) three times a day for 12.6 weeks as a food supply

Drug: Choline Chloride

Interventions

Choline Chloride DRUG

Choline Chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• male
• Cystic fibrosis is verified
• pancreatic insufficiency
• Decline of plasma phosphatidylcholine and steatosis of the liver
• informed consent is given

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

MeSH Terms

Interventions

Choline

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Joachim Riethmüller, PD

  Klinik für Kinder- und Jugendmedizin Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study to evolve the effect ot the treatment by comparing data before and after the treatment within the same patients

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 17, 2017
• Study Start: November 6, 2014
• Primary Completion: April 24, 2016
• Study Completion: February 8, 2017
• Last Updated: November 30, 2017

Record last verified: 2017-10