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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000036651
Receipt No. R000041752
Scientific Title The pilot study on evaluation of zinc supplementation in patients with liver cirrhosis
Date of disclosure of the study information 2019/05/05
Last modified on 2019/07/02

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Basic information
Public title The pilot study on evaluation of zinc supplementation in patients with liver cirrhosis
Acronym The evaluation of zinc supplementation in patients with liver cirrhosis
Scientific Title The pilot study on evaluation of zinc supplementation in patients with liver cirrhosis
Scientific Title:Acronym The evaluation of zinc supplementation in patients with liver cirrhosis
Region
Japan

Condition
Condition liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The zinc acetate hydrate preparation is administered to patients with liver cirrhosis, and changes in protein synthesis ability of the liver are evaluated.
Basic objectives2 Others
Basic objectives -Others To evaluate the change of latent hepatic encephalopathy by administering zinc acetate hydrate preparation to cirrhotic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Transthyretin changes
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administer 100 mg of zinc acetate hydrate (Nobelgin) daily for 12 weeks
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) A patient with liver cirrhosis who is taking a BCAA preparation with a serum ammonia concentration of 80 micro-g / dL or more and a serum zinc concentration of 80 micro-g / dL or less.
(2) Age at the time of consent is over 20 years old.
(3) Written informed consent has been obtained from the applicant.
Key exclusion criteria (1) Patients who do not meet selection criteria.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Tobita
Organization Shimane University Hospital
Division name Department of Hepatology
Zip code 693-8501
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2190
Email ht1020@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Tobita
Organization Shimane University Hospital
Division name Department of Hepatology
Zip code 693-8501
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2190
Homepage URL
Email ht1020@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
Institute
Department

Funding Source
Organization Shimane University 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 Shimane University Hospital
Address 89-1 Enya-cho, Izumo, Shimane
Tel 0853-20-2190
Email ht1020@med.shimane-u.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 島根大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 05 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 Terminated
Date of protocol fixation
2018 Year 02 Month 20 Day
Date of IRB
2018 Year 04 Month 06 Day
Anticipated trial start date
2018 Year 04 Month 06 Day
Last follow-up date
2019 Year 07 Month 02 Day
Date of closure to data entry
2019 Year 07 Month 02 Day
Date trial data considered complete
2019 Year 07 Month 02 Day
Date analysis concluded
2019 Year 07 Month 02 Day

Other
Other related information

Management information
Registered date
2019 Year 05 Month 05 Day
Last modified on
2019 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041752

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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