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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034536
Receipt No. R000039368
Scientific Title The influence on sarcopenia by administering zinc preparation for patients with cirrhosis with hypozincemia
Date of disclosure of the study information 2018/11/15
Last modified on 2018/10/17

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Basic information
Public title The influence on sarcopenia by administering zinc preparation for patients with cirrhosis with hypozincemia
Acronym Zinc and sarcopenia
Scientific Title The influence on sarcopenia by administering zinc preparation for patients with cirrhosis with hypozincemia
Scientific Title:Acronym Zinc and sarcopenia
Region
Japan

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

Objectives
Narrative objectives1 To examine the influence on sarcopenia by administering zinc preparation for patients with cirrhosis with hypozincemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of sarcopenia after 48 weeks
Key secondary outcomes Muscle mass and muscle strength
Energy metabolism
Protein metabolism
Baseline data
Visceral fat area

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Zinc preparation low dose group
25 mg twice daily
Interventions/Control_2 Zinc formulation high dose group
50 mg twice daily, after 4 weeks maximum dose 50 mg three times a day
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.Patients with histologically or radiologically confirmed liver cirrhosis with sarcopenia.
2.Patients with zinc deficiency related clinical symptom.
3.Patients with hypozincemia.
4.Patients with Child-Pugh score 10 or less.
5.Liver cirrhosis patients in whom ADL is maintained for more than one year and who are expected to consume a certain dietary amount.
6. Previous antiviral therapies or nutritional therapies for liver cirrhosis are not limited.
7. Patients with written informed consent by their free will after the full explanation of this study.
Key exclusion criteria 1.Patients with Child-Pugh score 11 or more.
2.Patients with severe underlying diseases.
3.Patients who were judged to be inappropriate for this study by attending physicians.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuhei Nishiguchi
Organization Hyogo college of medicine
Division name Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
Address 1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL 0798-45-6472
Email kantan@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Yoh
Organization Hyogo college of medicine
Division name Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
Address 1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL 0798-45-6472
Homepage URL
Email mm2wintwin@ybb.ne.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization Nobelpharma Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 11 Month 15 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
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 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
2018 Year 10 Month 17 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039368

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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