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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008524
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kanazawa University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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