UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030589
Receipt No. R000034866
Scientific Title Assessment of sarcopenic state in liver diseases and treatment efficacy by carnitine supplementation
Date of disclosure of the study information 2018/03/01
Last modified on 2018/11/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Assessment of sarcopenic state in liver diseases and treatment efficacy by carnitine supplementation
Acronym Assessment of sarcopenic state and treatment efficacy in liver diseases
Scientific Title Assessment of sarcopenic state in liver diseases and treatment efficacy by carnitine supplementation
Scientific Title:Acronym 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
1st name
Middle name
Last name Akinobu Takaki
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterology and Hepatology
Zip code
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
1st name
Middle name
Last name Takuya Adachi
Organization Okayama university hospital
Division name Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
No case was admitted.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 02 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000034866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.