Liver cirrhosis, Sarcopenia Liver cirrhosis, Sarcopenia
Conditions
Interventions
Subjects will be randomly assigned into two groups.
Low-dose group:
NOBELZINR25 mg twice daily
High-dose group:
NOBELZINR 50 mg twice daily and after 4 weeks maximum dose of 50 mg once three times a d
Zinc deficiency, Zinc preparation, Randomized controlled trial
Sponsors
Nishiguchi Shuhei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or radiologically confirmed liver cirrhosis with sarcopenia. 2. Patients with zinc deficiency-related clinical symptoms (*) 3.Patients with hypozincemia 4. Patients aged 20 years or more 5. Patients with Child-Pugh score 10 or less 6. Liver cirrhosis patients in whom ADL is maintained more than one year and who are expected to consume a certain dietary amount 7. Antiviral therapies or nutritional therapies such as BCAA granules are not limited. 8. Patients with written informed consent by their free will after the full explanation of this study. (*) Clinical symptoms and clinical signs of zinc deficiency include consciousness disturbance, muscle tension reduction, muscle weakness, severe cramps, severe fatigue, encephalopathy, emesis induced by hungry/infection and frequent vomiting. Zinc deficiency-related laboratory findings include hyperammonemia, hepatic dysfunction and fatty liver, electrolyte abnormalities, refractory anemia and hypo-ketonic hypoglycemia.
Exclusion criteria
Exclusion criteria: 1.Patients with Child-Pugh score 11 or more 2.Patients with severe underlying disease such as advanced malignancies or severe infectious diseases. 3.Patients who were judged to be inappropriate for the study subjects by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of sarcopenia after 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Muscle mass and body composition as assessed by BIA Hand grip strength Energy metabolism as assessed by indirect calorimetry Protein metabolism Baseline data Visceral fat area | — |
Contacts
Public ContactKazunori Yoh
The hospital of Hyogo College of Medicine
Outcome results
None listed