UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013760 |
|---|---|
| Receipt number | R000016060 |
| Scientific Title | A nutrition care support and efficacy of Levocarnitine Chloride(We change it to Levocarnitine from May 15,2015) in patients with NAFLD patients |
| Date of disclosure of the study information | 2014/04/18 |
| Last modified on | 2017/10/20 16:31:54 |
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Basic information
Public title
A nutrition care support and efficacy of Levocarnitine Chloride(We change it to Levocarnitine from May 15,2015) in patients with NAFLD patients
Acronym
Effect of the carnitine on NAFLD
Scientific Title
A nutrition care support and efficacy of Levocarnitine Chloride(We change it to Levocarnitine from May 15,2015) in patients with NAFLD patients
Scientific Title:Acronym
Effect of the carnitine on NAFLD
Region
| Japan |
Condition
Condition
NAFLD
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify the effect of the nutrition education and a liver function improvement effect with the carnitine administration on NAFLD patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
hematologic biochemical test
(AST･ALT･gamma-GTP･TC･LDL･TG･FBS･UA･insulin･IRI･Fe･Ferritin)
Body fat measurement using CT
physical measurement
body component analysis(In Body)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
The follow-up by the nutrition education 3 months
Levocarnitine Chloride at a600mg(We change it to Levocarnitine at a500mg from May 15,2015) thrice daily 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who had a diagnosis of NAFLD by liver biopsy with using echo guide in this hospital
Key exclusion criteria
Pacemaker wearing
The metal patients who enter who we have history of bone fracture, and are artificial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | seiko Yamaguchi |
Organization
Osaka city Juso hospital
Division name
Department of Gastroenterology,Internal Medicine
Zip code
Address
2-12-27 nonakakita,yodogawa-ku,Osaka city
TEL
06-6150-8000
seiko_y1226@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | seiko Yamaguchi |
Organization
Osaka city Juso hospital
Division name
Department of Gastroenterology,Internal Medicine
Zip code
Address
2-12-27 nonakakita,yodogawa-ku,Osaka city
TEL
06-6150-8000
Homepage URL
seiko_y1226@yahoo.co.jp
Sponsor or person
Institute
Osaka city Juso hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka city Juso hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka city university Faculty of Human life Science
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
大阪市立十三市民病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 18 | 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
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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 18 | Day |
Last modified on
| 2017 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016060
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
