UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034536
Receipt number 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 08:09:22

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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 or person

Institute

Hyogo college of medicine

Institute

Department

Personal name



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

Value
https://center6.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