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Randomized Controlled Trial
. 2020 Sep;35(5):1074-1083.
doi: 10.3904/kjim.2018.273. Epub 2019 Nov 12.

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

Jae Yoon Jeong  1 , Dae Won Jun  2 , Sol Ji Park  3 , Joo Hyun Sohn  1 , Sang Gyune Kim  4 , Se Whan Lee  5 , Soung Won Jeong  6 , Moon Young Kim  7 , Won Kim  8 , Jae-Jun Shim  9 , Hyoung Su Kim  10 , Ki Tae Suk  11 , Sang Bong Ahn  12
Affiliations
Randomized Controlled Trial

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

Jae Yoon Jeong et al. Korean J Intern Med. 2020 Sep.

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).

Conclusion: Vitamin D supplement did not increase SVR in treatment naïve patients with CHC irrespective of genotype.

Keywords: Chronic hepatitis C; Sustained virologic response; Vitamin D.

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Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

Figures

Figure 1.
Figure 1.
Flow diagram of enrolled patients. PEG, pegylated; RBV, ribavirin.
Figure 2.
Figure 2.
Sustained virologic response (SVR) between control group and vitamin D group in intention to treat analysis.
See this image and copyright information in PMC

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