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 2023/10/03 21:38:48

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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

Email

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


Email

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

Email

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



Management information

Registered date

2018 Year 03 Month 30 Day

Last modified on

2023 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036542


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name