UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the efficacy of social contribution for patients with NAFLD to motivate to start and continue the treatment.
Acronym	Investigation of the efficacy of social contribution for NAFLD patients to motivate the treatment.
Scientific Title	Investigation of the efficacy of social contribution for patients with NAFLD to motivate to start and continue the treatment.
Scientific Title:Acronym	Investigation of the efficacy of social contribution for NAFLD patients to motivate the treatment.
Region	Japan

Condition
Condition	NAFLD
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether decreased transaminase level makes the contribution to UNICEF is useful for NAFLD to start and continue the treatment .
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement of NAFLD at 3 years after starting this intervention
Key secondary outcomes	Improvement of ALT levels at 3 month after starting this intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Patients will continue the treatment and differences of paired ALT levels (ALT at every 3 month - ALT at baseline) will be evaluated at every 3 month after registration of this study. 1 IU/L of differences of paired ALT levels will be converted 10-yen and total amount will be contributed to UNICEF.
Interventions/Control_2	Patients will continue the treatment and differences of paired ALT levels (ALT at every 3 month - ALT at baseline) will be evaluated at every 3 month after registration of this study. Differences will not be contributed to UNICEF. (control group)
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	NAPLD patients with ALT levels were persisting upper 31 IU/L for 1 year or more.
Key exclusion criteria	patient with other chronic liver disease. patient with pregnancy. Drug induced fatty liver patient with disease associated with fatty liver (polycystic ovary disease, hypothyroidism, obstructive sleep apnea syndrome, hypopituitarism, hypogonadism, after an operation of pancreaticoduodenectomy)
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazuhito Middle name Last name Kawata
Organization	Hamamatsu University School of Medicine
Division name	Department of Internal Medicine II
Zip code	4313192
Address	1-20-1 Handayama Higashiku Hamamatsu
TEL	053-435-2263
Email	kawata@hama-med.ac.jp

Public contact
Name of contact person	1st name Kazuhito Middle name Last name Kawata
Organization	Hamamatsu University School of Medicine
Division name	Department of Internal Medicine II
Zip code	4313192
Address	1-20-1 Handayama Higashiku Hamamatsu
TEL	053-435-2263
Homepage URL
Email	kawata@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	none
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	Hamamatsu University School of Medicine
Address	1-20-1 Handayama Higashiku Hamamatsu
Tel	053-435-2680
Email	rinri@hama-med.ac.jp

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	2016 Year 01 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	33
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	2015 Year 08 Month 21 Day
Date of IRB	2015 Year 08 Month 04 Day
Anticipated trial start date	2015 Year 10 Month 20 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry	2020 Year 07 Month 31 Day
Date trial data considered complete	2020 Year 07 Month 31 Day
Date analysis concluded	2020 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 01 Month 16 Day
Last modified on	2020 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023714