UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020592
Receipt number 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 22:46:11

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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 or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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