Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study

Autor: 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
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: The Korean Journal of Internal Medicine, Vol 35, Iss 5, Pp 1074-1083 (2020)
Druh dokumentu: article
ISSN: 1226-3303
2005-6648
DOI: 10.3904/kjim.2018.273
Popis: 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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