Mohammad Abbasinazari1, Seyed Moayed Alavian2, Bita Behnava3, Mansour Asgharinia4, Shima Salimi3, Maryam Keshvari3, Leala Mehrnoush3, Pegah Karim5. 1. Faculty, Department of Clinical Pharmacy, Shahid Beheshti University of Medical Sciences , Tehran, Iran . 2. Faculty, Baqiyatallah Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences , Tehran, Iran; Middle East Liver Disease,Tehran, Iran . 3. Faculty, Baqiyatallah Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences , Tehran, Iran . 4. Faculty, Students Research Committee, School of Pharmacy, Shahid Beheshti University of Medical Sciences , Tehran, Iran . 5. Faculty, Iranian Blood Transfusion Organization Reaserch Center , Tehran, Iran .
Abstract
INTRODUCTION: Zinc deficiency has been reported in patients with both hepatitis C and beta thalassemia major. Zinc supplementation in addition to antiviral therapy of chronic hepatitis C has been accompanied by some success in patients with chronic hepatitis C. OBJECTIVE: The aim of the present pilot study is to determine the effect of 30 mg elemental zinc on biochemical and virological response in a population of patients with chronic hepatitis C with beta thalassemia major. MATERIALS AND METHODS: A prospective, double blind,placebo controlled trial included 40 patients being treated withPegylated interferon Alfa (Peg IFN-α) and ribavirin. Biochemical and virological parameters and plasma zinc levels were determined before starting treatment. Patients were randomly selected to receive either zinc or a placebo in addition to Peg IFN-α and ribavirin for a period of one year. AST, ALT, sustained viral response (SVR), and zinc levels were measured after treatment.Of the original 40 eligible patients, eight withdrawn from the study and 32 patients completed the study; 16 in the zinc group and 16 in the placebo group. Analysis of the data shows that there is no difference between the two groups in AST, ALT, SVR or zinc level following one year of treatment (p=0.224, p=0.616, p=0.670, p=0.999, respectively). CONCLUSION: The results of this study indicate that using 30 mg/day elemental zinc did not significantly improve the outcome of treatment in thalassemia patients with chronic hepatitis C. In future studies, we recommend trying higher doses zinc in patients with hepatitis C who had beta thalassemia major.
RCT Entities:
INTRODUCTION:Zinc deficiency has been reported in patients with both hepatitis C and beta thalassemia major. Zinc supplementation in addition to antiviral therapy of chronic hepatitis C has been accompanied by some success in patients with chronic hepatitis C. OBJECTIVE: The aim of the present pilot study is to determine the effect of 30 mg elemental zinc on biochemical and virological response in a population of patients with chronic hepatitis C with beta thalassemia major. MATERIALS AND METHODS: A prospective, double blind,placebo controlled trial included 40 patients being treated with Pegylated interferon Alfa (Peg IFN-α) and ribavirin. Biochemical and virological parameters and plasma zinc levels were determined before starting treatment. Patients were randomly selected to receive either zinc or a placebo in addition to Peg IFN-α and ribavirin for a period of one year. AST, ALT, sustained viral response (SVR), and zinc levels were measured after treatment.Of the original 40 eligible patients, eight withdrawn from the study and 32 patients completed the study; 16 in the zinc group and 16 in the placebo group. Analysis of the data shows that there is no difference between the two groups in AST, ALT, SVR or zinc level following one year of treatment (p=0.224, p=0.616, p=0.670, p=0.999, respectively). CONCLUSION: The results of this study indicate that using 30 mg/day elemental zinc did not significantly improve the outcome of treatment in thalassemiapatients with chronic hepatitis C. In future studies, we recommend trying higher doses zinc in patients with hepatitis C who had beta thalassemia major.
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