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Randomized Controlled Trial Multicenter Study
Effect of zinc on liver cirrhosis with hyperammonemia: a preliminary randomized, placebo-controlled double-blind trial.
- Kazuhiro Katayama, Masanori Saito, Takumi Kawaguchi, Ryujin Endo, Kei Sawara, Shuhei Nishiguchi, Akinobu Kato, Hiroshi Kohgo, Kazutomo Suzuki, Isao Sakaida, Yoshiyuki Ueno, Daiki Habu, Toshifumi Ito, Hisataka Moriwaki, and Kazuyuki Suzuki.
- Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center of Cancer and Cardiovascular Diseases, Osaka, Japan. Electronic address: katayama-ka@mc.pref.osaka.jp.
- Nutrition. 2014 Nov 1; 30 (11-12): 1409-14.
ObjectiveTo our knowledge, no randomized study has shown whether zinc replacement therapy is effective for hyperammonemia in liver cirrhosis; therefore, we performed a double-blind, placebo-controlled trial to examine efficacy and safety of the zinc replacement therapy.MethodsPatients with liver cirrhosis and hyperammonemia (at or above the institutional reference value) and hypozincemia (≤65 μg/dL) were enrolled in the outpatient units of the participating institutions and were randomly divided to receive placebo (P group) or zinc acetate preparation at a dose of 3 capsules/d for a total zinc content of 150 mg/d (Z group) by the envelope method. Of the 18 enrolled patients, 6 dropped out; thus, the analyses included 12 patients (5 in the P group and 7 in the Z group). Variations in blood concentrations of zinc and ammonia as well as liver function test results were compared.ResultsBlood zinc levels significantly increased in the Z group (P = 0.0037; Friedman test) but not the P group. Blood ammonia levels significantly decreased in the Z group (P = 0.0114; Friedman test) but not the P group. The percent change in blood ammonia level also revealed significant reduction at the eighth week in the Z group (P = 0.0188: Mann-Whitney test). No serious adverse events attributable to the zinc preparation were noted.ConclusionAlthough this study is preliminary and includes a small sample, it is, to our knowledge, the first randomized controlled trial to show that zinc supplementation for 3 mo seems effective and safe for treating hyperammonemia in liver cirrhosis. Studies with a larger sample size are needed to confirm our findings.Copyright © 2014 Elsevier Inc. All rights reserved.
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