UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030589 |
|---|---|
| Receipt number | 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 13:01:55 |
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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
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
adataku719@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034866
