NIPH Clinical Trials Search

JRCT ID: jRCTs051180222

Registered date:27/03/2019

Zinc and sarcopenia in liver cirrhosis

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedLiver cirrhosis, Sarcopenia
Date of first enrollment01/02/2019
Target sample size35
Countries of recruitment
Study typeInterventional
Intervention(s)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 day


Primary OutcomeImprovement of sarcopenia after 48 weeks
Secondary OutcomeMuscle 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. 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.
Exclude criteria1.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.

Related Information


Public contact
Name Kazunori Yoh
Address 1-1, Mukogawa-cho, Nishinomiya-shi, Hyogo, Japan Hyogo Japan 663-8501
Telephone +81-798-45-6472
Affiliation The hospital of Hyogo College of Medicine
Scientific contact
Name Shuhei Nishiguchi
Address 1-1, Mukogawa-cho, Nishinomiya-shi, Hyogo Hyogo Japan 663-8501
Telephone +81-798-45-6472
Affiliation The hospital of Hyogo College of Medicine