UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009133 |
|---|---|
| Receipt number | R000010696 |
| Scientific Title | The Effect of Levocarnitine on the Patient with Non-alcoholic Fatty Liver Disease |
| Date of disclosure of the study information | 2012/10/17 |
| Last modified on | 2025/04/27 10:35:43 |
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Basic information
Public title
The Effect of Levocarnitine on the Patient with Non-alcoholic Fatty Liver Disease
Acronym
Levocarnitine for Treatment of Non-alcoholic Fatty Liver Disease
Scientific Title
The Effect of Levocarnitine on the Patient with Non-alcoholic Fatty Liver Disease
Scientific Title:Acronym
Levocarnitine for Treatment of Non-alcoholic Fatty Liver Disease
Region
| Japan |
Condition
Condition
Non-Alcoholic Fatty Liver Disease (NAFLD)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Several study have suggested that Levocarnitine is related to transportation of Fatty acid into mitochondria and the fat deposit to hepatocyte. However, no studies have been done to research the effect and mechanism of Levocarnitine on Non-Alcoholic Fatty Liver Disease(NAFLD).
Thus, the aim of this study is to research the efficacy and safety of Levocarnitine on the patient with NAFLD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of serum ALT after taking Levocarnitine for 6 months
Key secondary outcomes
The following items are assessed after taking Levocarnitine for 6 months
1. Safety
2. Improvement of metabolic disorder
3. Improvement of histological findings of the liver
4. the effect of Levocarnitine on the gene expression(mRNA)
5. The effect of Levocarnitine on immunoreaction in the liver
6. The concentration of the Levocarnitine and the effect of Levocarnitine on fatty acid composition in the liver
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Levocarnitine at a 600mg thrice daily for 6months
Interventions/Control_2
control
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who are
1. Diagnosed as NAFLD by histological examination.
2. Tolerable to take Levocarnicine for 6 month.
3. Child-Pugh classification A.
4. Age order than or equal to 20years old and younger than 80 yaers old at time of the consent.
5. Performance status(ECOG scale) 0 or 1.
6. The function of main organs should should be well maintained within 14 days before time of the consent.
6-1, WBC;greater than or equal to 3,000 and less than 12,000/uL
6-2, Hb;greater than or equal to 9.0g/dL
6-3, Platelet;greater than or equal to 70,000/uL
6-4, Total Bilirubin;less than or equal to 1.5mg/dL or lower than upper limit of the facility
6-5, Serum ALT;greater than upper limit of the facility and less than or equal to 300 U/L
6-6, Serum Cr;less than or equal to 1.2mg/dL or lower than upper limit of the facility
6-7, The patients have to agree to join this study by their free wills
Key exclusion criteria
The following patients should be excluded
1. Infected with HBV or HCV
2. Alcohol assumption per day; greater than 20g
3. Complicated with malignant disease including hepatocellular carcinoma
4. Complicated with obvious hepatic encephalopathy
5. Complicated with active infectious disease
6. Complicated with Critical complications
7. Nursing and Pregnant woman
8. Taking contraindicating medicines with Levocarnitine
9. Taking pioglitazone and metformin
10.the other patients who the doctors in charge consider should not enter this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamashita |
Organization
kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
9208641
Address
13-1, takaramachi, Kanazawa, Ishikawa
TEL
0762652235
ytatsuya@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamashita |
Organization
kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
9208641
Address
13-1, takaramachi, Kanazawa, Ishikawa
TEL
076-265-2235
Homepage URL
ytatsuya@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science, Disease Contral and Homeostasis
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Graduate School of Medical Science, Disease Contral and Homeostasis
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
Kanazawa University Hospital
Address
13-1 Takara-machi
Tel
0762652235
ytatsuya@m-kanazawa.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
5782
Org. issuing International ID_1
Knazawa University Hospital, Center for Clinical Research Management
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 17 | 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
| 2012 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010696
