UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020592
Receipt No. R000023714
Scientific Title Investigation of the efficacy of social contribution for patients with NAFLD to motivate to start and continue the treatment.
Date of disclosure of the study information 2016/01/18
Last modified on 2020/08/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000023714

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.