UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008524 |
|---|---|
| Receipt number | R000010021 |
| Scientific Title | A placebo-controlled trial of astaxanthin in subjects with nonalcoholic fatty liver disease |
| Date of disclosure of the study information | 2012/07/24 |
| Last modified on | 2012/07/24 22:01:50 |
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Basic information
Public title
A placebo-controlled trial of astaxanthin in subjects with nonalcoholic fatty liver disease
Acronym
AX-NAFLD-1
Scientific Title
A placebo-controlled trial of astaxanthin in subjects with nonalcoholic fatty liver disease
Scientific Title:Acronym
AX-NAFLD-1
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease (NAFLD)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Efficacy of astaxanthin in subjects of NAFLD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum alanine aminotransferase level
Key secondary outcomes
Histologic features of nonalcoholic steatohepatitis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Astaxanthin 12mg daily for 6 months
Interventions/Control_2
Placebo for 6 months
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who
1) are 18 and older at time fo consent, male of female
2) are histologically diagnosed as NAFLD by liver biopsy
3) have ALT 30 and higher
4) have alcohol intake 30 gram and less for male, and 20 gram and less for female
Key exclusion criteria
Subjects who
1) are infected with HBV or HCV
2) have alcohol intake more than 30 for male, and more than 20 gram for female
3) have malignant tumor including hepatocellular carcinoma
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuguhito Ota |
Organization
Kanazawa University
Division name
Department of Medicine
Zip code
Address
13-1 Takara-machi Kanazawa
TEL
076-265-2234
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuguhito Ota |
Organization
Kanazawa University
Division name
Department of Medicine
Zip code
Address
13-1 Takara-machi Kanazawa
TEL
076-2665-2234
Homepage URL
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 24 | Day |
Last modified on
| 2012 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010021
