Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label studyopen access
- Authors
- Jeong, Jae Yoon; Jun, Dae Won; Park, Sol Ji; Sohn, Joo Hyun; Kim, Sang Gyune; Lee, Se Whan; Jeong, Soung Won; Kim, Moon Young; Kim, Won; Shim, Jae-Jun; Kim, Hyoung Su; Suk, Ki Tae; Ahn, Sang Bong
- Issue Date
- Sep-2020
- Publisher
- KOREAN ASSOC INTERNAL MEDICINE
- Keywords
- Chronic hepatitis C; Vitamin D; Sustained virologic response
- Citation
- KOREAN JOURNAL OF INTERNAL MEDICINE, v.35, no.5, pp.1074 - 1083
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- KOREAN JOURNAL OF INTERNAL MEDICINE
- Volume
- 35
- Number
- 5
- Start Page
- 1074
- End Page
- 1083
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/8942
- DOI
- 10.3904/kjim.2018.273
- ISSN
- 1226-3303
- 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.
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