Zinc and sarcopenia in liver cirrhosis

JRCT ID: jRCTs051180222

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Liver cirrhosis, Sarcopenia
• Date of first enrollment: 01/02/2019
• Target sample size: 35
• Study type: Interventional

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

Outcome(s)

• Primary Outcome: Improvement of sarcopenia after 48 weeks

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nishiguchi Shuhei
• Source(s) of Monetary Support: Nobelpharma Co., Ltd.,Nobelpharma Co., Ltd.