Zinc replacement to mitigate muscle cramps in cirrhotic patients

• Grant number: 21/01176-1
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: December 01, 2021
• End date: November 30, 2022
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Fernando Gomes Romeiro
• Grantee: Teresa Chay Alves Mendoza
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Liver cirrhosis is the main cause of ascites, which impairs the quality of life of the patients and often requires diuretics usage. However, diuretics are not free from adverse events, including the reduction of zinc serum levels, which can lead to other complications such as muscle cramps. The aim of this study is to evaluate the efficacy of zinc supplementation to treat muscle cramps in cirrhotic outpatients. Methods: the study will be divided into two parts: the first one will be a retrospective evaluation of patients who had muscle cramps and received zinc supplementation. They will be asked about the number of muscle cramps they had weekly, the use of medications at that time, and whether they achieved complete remission, partial remission, or unsuccessful response to the zinc supplementation. The second part of the study will be a prospective, randomized, double-blind, and crossover clinical trial, when the subjects will receive 3 capsules of zinc sulfate or placebo, to be taken twice a day. This initial supplementation will last for two weeks. After that, the initial supplement will be changed to the other supplement (active treatment or placebo). After 4 weeks, the subject will enter the open phase of the study, with another 2 weeks of active treatment. Plasmatic zinc levels will be checked before the trial and every 2 weeks. The expected results can offer a new treatment option for muscle cramps in this setting. (AU)