UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011176 |
|---|---|
| Receipt number | R000013092 |
| Scientific Title | The'Donations for Decreased ALT (D4D)' prosocial behavior incentive scheme for NAFLD patients |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2013/07/11 17:48:24 |
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Basic information
Public title
The'Donations for Decreased ALT (D4D)' prosocial behavior incentive scheme for NAFLD patients
Acronym
D4D project
Scientific Title
The'Donations for Decreased ALT (D4D)' prosocial behavior incentive scheme for NAFLD patients
Scientific Title:Acronym
D4D project
Region
| Japan |
Condition
Condition
NAFLD
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether prosocial behaviour can become a motivating factor for the treatment of NAFLD
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
ALT decrease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
diet therapy
Interventions/Control_2
motivation therapy
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
NAFLD with ALT > or = 31 IU/L
Key exclusion criteria
HCC, decompensated LC
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Sumida |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kamigyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
sumida@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
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
| 2013 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | 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
| 2013 | Year | 07 | Month | 11 | Day |
Last modified on
| 2013 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013092
