UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of sarcopenic state in liver diseases and treatment efficacy by carnitine supplementation
Title of the study (Brief title)	Assessment of sarcopenic state and treatment efficacy in liver diseases
Region	Japan

Condition
Condition	sarcopenia in liver diseases
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of establishing the prevalence of sarcopenia in liver diseases and the treatment efficacy by carnitine supplementation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of sarcopenia in liver diseases, Treatment efficacy by carnitine supplementation(after 3months, after 6months)
Key secondary outcomes	serum ammonia neuropsychiatric function test

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	L-cartinFF 1500mg/day supplementation for 6 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who meets the criteria of sarcopenia in liver diseases by the Japan society of hepatology
Key exclusion criteria	1)The patient who has already taken carnitine 2)The patient equivalent to stageIV in hepatocellular carcinoma 3)The pregnant woman 4)The breast-feeding women 5)The patient who received other study medicine or the clinical experimental medicine within three months before dosage start of the study 6)In addition, the patient whom principal investigators judged to be inappropriate as a study subject
Target sample size	30

Research contact person
Name of lead principal investigator	Akinobu Takaki
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Address	2-5-1 Sikatacho, Kitaku, Okayama city, Okayama, japan
TEL	086-235-7219
Email	akitaka@md.okayama-u.ac.jp

Public contact
Name of contact person	Takuya Adachi
Organization	Okayama university hospital
Division name	Gastroenterology
Address	2-5-1 Sikatacho, Kitaku, Okayama city, Okayama, japan
TEL	086-235-7219
Homepage URL
Email	adataku719@yahoo.co.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	岡山大学病院

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 02 Month 28 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2018 Year 11 Month 08 Day
Date of closure to data entry	2018 Year 11 Month 08 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	No case was admitted.
Other related information

Management information
Registered date	2017 Year 12 Month 27 Day
Last modified on	2018 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034866