Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study
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 we...
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doaj-27be5217428043a295c313ecf16f1a4b2021-08-10T06:00:14ZengThe Korean Association of Internal MedicineThe Korean Journal of Internal Medicine1226-33032005-66482020-09-013551074108310.3904/kjim.2018.273170258Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label studyJae Yoon Jeong0Dae Won Jun1Sol Ji Park2Joo Hyun Sohn3Sang Gyune Kim4Se Whan Lee5Soung Won Jeong6Moon Young Kim7Won Kim8Jae-Jun Shim9Hyoung Su Kim10Ki Tae Suk11Sang Bong Ahn12 Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea Department of Internal Medicine, Hanyang University Hospital, Seoul, Korea Department of Clinical Pharmacology, Sungkyunkwan University, Seoul, Korea Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea Department of Internal Medicine, Eulji University School of Medicine, Seoul, KoreaBackground/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.http://www.kjim.org/upload/pdf/kjim-2018-273.pdfchronic hepatitis cvitamin dsustained virologic response |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jae Yoon Jeong Dae Won Jun Sol Ji Park Joo Hyun Sohn Sang Gyune Kim Se Whan Lee Soung Won Jeong Moon Young Kim Won Kim Jae-Jun Shim Hyoung Su Kim Ki Tae Suk Sang Bong Ahn |
spellingShingle |
Jae Yoon Jeong Dae Won Jun Sol Ji Park Joo Hyun Sohn Sang Gyune Kim Se Whan Lee Soung Won Jeong Moon Young Kim Won Kim Jae-Jun Shim Hyoung Su Kim Ki Tae Suk Sang Bong Ahn Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study The Korean Journal of Internal Medicine chronic hepatitis c vitamin d sustained virologic response |
author_facet |
Jae Yoon Jeong Dae Won Jun Sol Ji Park Joo Hyun Sohn Sang Gyune Kim Se Whan Lee Soung Won Jeong Moon Young Kim Won Kim Jae-Jun Shim Hyoung Su Kim Ki Tae Suk Sang Bong Ahn |
author_sort |
Jae Yoon Jeong |
title |
Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study |
title_short |
Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study |
title_full |
Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study |
title_fullStr |
Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study |
title_full_unstemmed |
Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study |
title_sort |
effects of vitamin d supplements in patients with chronic hepatitis c: a randomized, multi-center, open label study |
publisher |
The Korean Association of Internal Medicine |
series |
The Korean Journal of Internal Medicine |
issn |
1226-3303 2005-6648 |
publishDate |
2020-09-01 |
description |
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. |
topic |
chronic hepatitis c vitamin d sustained virologic response |
url |
http://www.kjim.org/upload/pdf/kjim-2018-273.pdf |
work_keys_str_mv |
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