UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032023 |
|---|---|
| Receipt number | R000036542 |
| Scientific Title | The study for usefullness of zinc administration in patients with chronic liver diseases |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2025/04/04 14:22:30 |
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Basic information
Public title
The study for usefullness of zinc administration in patients with chronic liver diseases
Acronym
ZINC THINK study
Scientific Title
The study for usefullness of zinc administration in patients with chronic liver diseases
Scientific Title:Acronym
ZINC THINK study
Region
| Japan | Asia(except Japan) |
Condition
Condition
chronic liver diseases
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the long-term usefullness and safety of zinc administration in patients with chronic liver diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cumulative survival rate, HCC incidence rate, event incidence rate(varix rupture,refractory pleural effusion/ascites, and cancer development), liver function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of zinc preparation(zinc acetate, zinc sulfate)(one year)
50-150mg zinc equivalent
Interventions/Control_2
without taking zinc preparation
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
| 999999999999999999 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 patients diagnosed as chronic liver diseases
2 patients are not taking zinc preparation
Key exclusion criteria
1 patients who are considered to be inappropriate for this study by atttending physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hosui |
Organization
Osaka-Rosai Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
591-8025
Address
1179-3, nagasonecho, Kitaku, Sakai city, Osaka
TEL
072-252-3561
hosui@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hosui |
Organization
Osaka-Rosai Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
591-8025
Address
1179-3, nagasonecho, Kitaku, Sakai city, Osaka
TEL
072-252-3561
Homepage URL
hosui@osakah.johas.go.jp
Sponsor or person
Institute
Osaka-Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka-Rosai Hospital
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
IRB in Osaka-Rosai Hospital
Address
Nagasonecho, Kitaku, Sakai city
Tel
072-252-3561
shounai-hisho@osakah.johas.go.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
| 2018 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2028 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2031 | Year | 04 | Month | 03 | Day |
Other
Other related information
Interim analysis has been done in 2023 and will be presented in the Japan Society of Hepatology 2024, on June 14th.
Now, the manuscript has been prepared for submission.
Management information
Registered date
| 2018 | Year | 03 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036542
