Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Background/Aims: We aimed to assess the role of vitamin D supplementation in the response to pegylated interferon-α (PEG-IFN-α) plus ribavirin (RBV) treatment in patients with chronic hepatitis C (CHC). Methods: Our study was a multi-center, randomized controlled trial in 11 hospitals. CHC patients were randomly assigned (1:1) to two groups namely, PEGIFN-α plus RBV (control group) or PEG-IFN-α plus RBV + vitamin D (800 IU daily) (vitamin D group). The primary end-point was the rate of sustained virologic response (SVR). Results: One hundred forty eight CHC patients were randomly assigned to two groups. Seventy-one patients received the PEG-IFN-α plus RBV and 77 patients received the PEG-IFN-α plus RBV + vitamin D. A total of 105 patients completed the study (control group, 47 vs. vitamin D group, 58). Baseline characteristics were mostly similar in both the groups. There was a modest but non-significant increase in SVR in the vitamin D group compared to the control group with the intention to treat analysis (64.0% vs. 49.3 %, p = 0.071) as well as in the per protocol analysis (control group vs. vitamin D group: 74.5% vs. 84.5%, p = 0.202). Fifty-two patients (73.2%) in the control group and 63 patients (81.8%) in the vitamin D group experienced at least one adverse event. The drop-out rate due to adverse effects was not different between both groups (control group vs. vitamin D group: 19.7% vs. 10.4%, p = 0.111). Conclusions: Vitamin D supplement did not increase SVR in treatment naïve patients with CHC irrespective of genotype.
Abstract
Background/Aims: We aimed to assess the role of vitamin D supplementation in the response to pegylated interferon-α (PEG-IFN-α) plus ribavirin (RBV) treatment in patients with chronic hepatitis C (CHC). Methods: Our study was a multi-center, randomized controlled trial in 11 hospitals. CHC patients were randomly assigned (1:1) to two groups namely, PEGIFN-α plus RBV (control group) or PEG-IFN-α plus RBV + vitamin D (800 IU daily) (vitamin D group). The primary end-point was the rate of sustained virologic response (SVR). Results: One hundred forty eight CHC patients were randomly assigned to two groups. Seventy-one patients received the PEG-IFN-α plus RBV and 77 patients received the PEG-IFN-α plus RBV + vitamin D. A total of 105 patients completed the study (control group, 47 vs. vitamin D group, 58). Baseline characteristics were mostly similar in both the groups. There was a modest but non-significant increase in SVR in the vitamin D group compared to the control group with the intention to treat analysis (64.0% vs. 49.3 %, p = 0.071) as well as in the per protocol analysis (control group vs. vitamin D group: 74.5% vs. 84.5%, p = 0.202). Fifty-two patients (73.2%) in the control group and 63 patients (81.8%) in the vitamin D group experienced at least one adverse event. The drop-out rate due to adverse effects was not different between both groups (control group vs. vitamin D group: 19.7% vs. 10.4%, p = 0.111). Conclusions: Vitamin D supplement did not increase SVR in treatment naïve patients with CHC irrespective of genotype.
참고문헌 (36)
- Rahman AH, "Vitamin D for your patients with chronic hepatitis C", J Hepatol, 58, pp.184~189 (2013)
- Holick MF, "Vitamin D : importance in the prevention of cancers, type 1 diabetes, heart disease, and osteoporosis", Am J Clin Nutr, 79, pp.362~371 (2004)
- Giovannucci E, "Prospective study of predictors of vitamin D status and cancer incidence and mortality in men", J Natl Cancer Inst, 98, pp.451~459 (2006)
- Dobnig H, "Independent association of low serum 25-hydroxyvitamin d and 1, 25-dihydroxyvitamin d levels with all-cause and cardiovascular mortality", Arch Intern Med, 168, pp.1340~1349 (2008)
- Liu PT, "Toll-like receptor triggering of a vitamin D-mediated human antimicrobial response", Science, 311, pp.1770~1773 (2006)
- Ross AC, "The 2011 report on dietary reference intakes for calcium and vitamin D", Public Health Nutr, 14, pp.938~939 (2011)
- Holick MF, "Prevalence of vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy", J Clin Endocrinol Metab, 90, pp.3215~3224 (2005)
- Lips P, "The prevalence of vitamin D inadequacy amongst women with osteoporosis : an international epidemiological investigation", J Intern Med, 260, pp.245~254 (2006)
- Orwoll E, "Vitamin D deficiency in older men", J Clin Endocrinol Metab, 94, pp.1214~1222 (2009)
- Forrest KY, "Prevalence and correlates of vitamin D deficiency in US adults", Nutr Res, 31, pp.48~54 (2011)
- Cashman KD, "Vitamin D deficiency in Europe : pandemic", Am J Clin Nutr, 103, pp.1033~1044 (2016)
- Akter S, "Serum 25-hydroxyvitamin D and metabolic syndrome in a Japanese working population : the Furukawa Nutrition and Health Study", Nutrition, 36, pp.26~32 (2017)
- Fisher L, "Vitamin D and parathyroid hormone in outpatients with noncholestatic chronic liver disease", Clin Gastroenterol Hepatol, 5, pp.513~520 (2007)
- Garcia-Alvarez M, "Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy : a meta-analysis", Hepatology, 60, pp.1541~1550 (2014)
- Petta S, "Low vitamin D serum level is related to severe fibrosis and low responsiveness to interferon-based therapy in genotype 1 chronic hepatitis C", Hepatology, 51, pp.1158~1167 (2010)
- Ford ES, "Concentrations of serum vitamin D and the metabolic syndrome among U. S. adults", Diabetes Care, 28, pp.1228~1230 (2005)
- Ford ES, "Serum concentrations of vitamin D and parathyroid hormone and prevalent metabolic syndrome among adults in the United States", J Diabetes, 1, pp.296~303 (2009)
- Lu L, "Plasma 25-hydroxyvitamin D concentration and metabolic syndrome among middle-aged and elderly Chinese individuals", Diabetes Care, 32, pp.1278~1283 (2009)
- Bitetto D, "Vitamin D supplementation improves response to antiviral treatment for recurrent hepatitis C", Transpl Int, 24, pp.43~50 (2011)
- Abu-Mouch S, "Vitamin D supplementation improves sustained virologic response in chronic hepatitis C(genotype 1)-naive patients", World J Gastroenterol, 17, pp.5184~5190 (2011)
- Nimer A, "Vitamin D improves viral response in hepatitis C genotype 2-3 naïve patients", World J Gastroenterol, 18, pp.800~805 (2012)
- Yokoyama S, "Effect of vitamin D supplementation on pegylated interferon", ribavirin therapy for chronic hepatitis C genotype 1b : a randomized controlled trial, 2014, pp.21, 348~356
- Esmat G, "Impact of vitamin D supplementation on sustained virological response in chronic hepatitis C genotype 4 patients treated by pegylated interferon", ribavirin, 2015, pp.35, 49~54
- Kitson MT, "Vitamin D level and sustained virologic response to interferon-based antiviral therapy in chronic hepatitis C : a systematic review and meta-analysis", J Hepatol, 61, pp.1247~1252 (2014)
- Korean Association for the Study of the Liver, "KASL clinical practice guidelines: management of hepatitis C", Clin Mol Hepatol, 20, pp.89~136 (2014)
- Stokes CS, "Vitamin D in chronic liver disease", Liver Int, 33, pp.338~352 (2013)
- Itoh Y, "Serum levels of soluble tumor necrosis factor receptors and effects of interferon therapy in patients with chronic hepatitis C virus infection", Am J Gastroenterol, 94, pp.1332~1340 (1999)
- Larrubia JR, "Role of chemokines and their receptors in viral persistence and liver damage during chronic hepatitis C virus infection", World J Gastroenterol, 14, pp.7149~7159 (2008)
- Abramovitch S, "Vitamin D inhibits proliferation and profibrotic marker expression in hepatic stellate cells and decreases thioacetamide-induced liver fibrosis in rats", Gut, 60, pp.1728~1737 (2011)
- Komolmit P, "Vitamin D supplementation improves serum markers associated with hepatic fibrogenesis in chronic hepatitis C patients : a randomized, double-blind, placebo-controlled study", Sci Rep, 7, pp.8905~ (2017)
- Gal-Tanamy M, "Vitamin D : an innate antiviral agent suppressing hepatitis C virus in human hepatocytes", Hepatology, 54, pp.1570~1579 (2011)
- Grasso A, "Insulin resistance predicts rapid virological response in non-diabetic, non-cirrhotic genotype 1 HCV patients treated with peginterferon alpha-2b plus ribavirin", J Hepatol, 51, pp.984~990 (2009)
- Kim HB, "Efficacy of vitamin D supplementation in combination with conventional antiviral therapy in patients with chronic hepatitis C infection:a meta-analysis of randomised controlled trials", J Hum Nutr Diet, 31, pp.168~177 (2018)
- Lange CM, "Vitamin D deficiency and a CYP27B1-1260 promoter polymorphism are associated with chronic hepatitis C and poor response to interferon-alfa based therapy", J Hepatol, 54, pp.887~893 (2011)
- Backstedt D, "25-Vitamin D levels in chronic hepatitis C infection : association with cirrhosis and sustained virologic response", Ann Gastroenterol, 30, pp.344~348 (2017)
- Lee SM, "Vitamin D deficiency in non-alcoholic fatty liver disease : the chicken or the egg", Clin Nutr, 36, pp.191~197 (2017)