Unique ID issued by UMIN | UMIN000034536 |
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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 |
The influence on sarcopenia by administering zinc preparation for patients with cirrhosis with hypozincemia
Zinc and sarcopenia
The influence on sarcopenia by administering zinc preparation for patients with cirrhosis with hypozincemia
Zinc and sarcopenia
Japan |
Liver cirrhosis
Hepato-biliary-pancreatic medicine |
Others
NO
To examine the influence on sarcopenia by administering zinc preparation for patients with cirrhosis with hypozincemia.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Improvement of sarcopenia after 48 weeks
Muscle mass and muscle strength
Energy metabolism
Protein metabolism
Baseline data
Visceral fat area
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
2
Treatment
Medicine |
Zinc preparation low dose group
25 mg twice daily
Zinc formulation high dose group
50 mg twice daily, after 4 weeks maximum dose 50 mg three times a day
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
35
1st name | |
Middle name | |
Last name | Shuhei Nishiguchi |
Hyogo college of medicine
Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
0798-45-6472
kantan@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Kazunori Yoh |
Hyogo college of medicine
Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
0798-45-6472
mm2wintwin@ybb.ne.jp
Hyogo college of medicine
Nobelpharma Co., Ltd.
Profit organization
NO
2018 | Year | 11 | Month | 15 | Day |
Unpublished
Preinitiation
2018 | Year | 10 | Month | 01 | Day |
2018 | Year | 11 | Month | 01 | Day |
2018 | Year | 10 | Month | 17 | Day |
2018 | Year | 10 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039368
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