UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036651 |
|---|---|
| Receipt number | 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 | 2020/01/15 19:56:26 |
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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
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
ht1020@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
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
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
8
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
| 2020 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041752
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| Registered date | File name |
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