Effects of Zinc Acetate on Serum Zinc Concentrations in Chronic Liver Diseases: a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial and a ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-08-07

AUTHORS

Kazuhiro Katayama, Atsushi Hosui, Yoshiyuki Sakai, Minoru Itou, Yasushi Matsuzaki, Yoriyuki Takamori, Keiko Hosho, Tomomi Tsuru, Yasuhiro Takikawa, Kojiro Michitaka, Eishin Ogawa, Yoko Miyoshi, Toshifumi Ito, Shinobu Ida, Izumi Hamada, Katsunori Miyoshi, Hiroko Kodama, Tetsuo Takehara

ABSTRACT

The essential trace element zinc maintains liver functions. Liver diseases can alter overall zinc concentrations, and hypozincemia is associated with various hepatic pathologies. Modulating systemic zinc through dietary supplementation is potentially useful for liver diseases. We evaluated the usefulness of zinc (NPC-02; acetate formulation) supplementation. We conducted two NPC-02 studies on zinc-deficient patients (serum zinc < 70 μg/dL). Study 1: double-blind, randomized, placebo-controlled trial on 57 subjects with chronic liver diseases comparing serum zinc in patients given NPC-02 (NPC-02 group) versus placebo (Placebo group). Study 2: dose adjustment study on 43 subjects with/without liver diseases to determine proportions maintaining serum zinc target (≥ 80 μg/dL but < 200 μg/dL). In study 1, NPC-02 subjects had higher serum zinc concentrations at week 8 than Placebo subjects (83.2 ± 20.2 and 61.3 ± 12.0, respectively; P < 0.0001), and more NPC-02 than Placebo subjects achieved the serum zinc target (15/27 vs. 1/26). In study 2, the NPC-02-induced serum zinc increase was dose-dependent in subjects both with and without liver diseases (r = 0.5143, P = 0.0022 and r = 0.5753, P = 0.0005, respectively). Interestingly, there was a marginally positive correlation between serum zinc and albumin levels in subjects with but not in those without liver diseases (r = 0.4028, P = 0.0631 and r = 0.1360, P = 0.5567, respectively). NPC-02 dose-dependently increases serum zinc in hypozincemic patients, regardless of liver disease. NPC-02 is a potentially effective therapy for liver cirrhosis, in which zinc deficiency is common. Clinical trial registry number: NCT02337569, NCT02321865. More... »

PAGES

71-81

References to SciGraph publications

Journal

TITLE

Biological Trace Element Research

ISSUE

1

VOLUME

195

Author Affiliations

  • Department of Hepato-biliary and Pancreatic Oncology, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, 541-8567, Osaka, Japan
  • Department of Gastroenterology and Hepatology, Osaka Rosai Hospital, Osaka, Japan
  • Division of Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan
  • Department of Internal Medicine, Kurume Clinical Pharmacology Clinic, Fukuoka, Japan
  • Department of Gastroenterology and Hepatology, Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan
  • Department of Internal Medicine, Teikyo University Hospital, Tokyo, Japan
  • 2nd Department of Internal Medicine, Tottori University Hospital, Tottori, Japan
  • Department of Rheumatology, PS Clinic, Fukuoka, Japan
  • Division of Hepatology, Department of Internal Medicine, Iwate Medical University Hospital, Iwate, Japan
  • Department of Gastroenterology, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan
  • Department of Pediatrics, Teikyo University Hospital, Tokyo, Japan
  • Department of Pediatrics, Osaka University Graduate School of Medicine, Osaka, Japan
  • Department of Gastroenterology and Hepatology, Japan Community Healthcare Organization Osaka Hospital, Osaka, Japan
  • Department of Pediatric Gastroenterology and Nutrition, Osaka Women’s and Children’s Hospital, Osaka, Japan
  • Department of Research and Development, Nobelpharma Co., Ltd., Tokyo, Japan
  • Department of Health and Dietetics, Faculty of Health and Medical Science, Teikyo Heisei University, Tokyo, Japan
  • Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s12011-019-01851-y

    DOI

    http://dx.doi.org/10.1007/s12011-019-01851-y

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1120190856

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/31392541


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    19 schema:description The essential trace element zinc maintains liver functions. Liver diseases can alter overall zinc concentrations, and hypozincemia is associated with various hepatic pathologies. Modulating systemic zinc through dietary supplementation is potentially useful for liver diseases. We evaluated the usefulness of zinc (NPC-02; acetate formulation) supplementation. We conducted two NPC-02 studies on zinc-deficient patients (serum zinc < 70 μg/dL). Study 1: double-blind, randomized, placebo-controlled trial on 57 subjects with chronic liver diseases comparing serum zinc in patients given NPC-02 (NPC-02 group) versus placebo (Placebo group). Study 2: dose adjustment study on 43 subjects with/without liver diseases to determine proportions maintaining serum zinc target (≥ 80 μg/dL but < 200 μg/dL). In study 1, NPC-02 subjects had higher serum zinc concentrations at week 8 than Placebo subjects (83.2 ± 20.2 and 61.3 ± 12.0, respectively; P < 0.0001), and more NPC-02 than Placebo subjects achieved the serum zinc target (15/27 vs. 1/26). In study 2, the NPC-02-induced serum zinc increase was dose-dependent in subjects both with and without liver diseases (r = 0.5143, P = 0.0022 and r = 0.5753, P = 0.0005, respectively). Interestingly, there was a marginally positive correlation between serum zinc and albumin levels in subjects with but not in those without liver diseases (r = 0.4028, P = 0.0631 and r = 0.1360, P = 0.5567, respectively). NPC-02 dose-dependently increases serum zinc in hypozincemic patients, regardless of liver disease. NPC-02 is a potentially effective therapy for liver cirrhosis, in which zinc deficiency is common. Clinical trial registry number: NCT02337569, NCT02321865.
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