Korean J Intern Med.  2020 Sep;35(5):1074-1083. 10.3904/kjim.2018.273.

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

Affiliations
  • 1Department of Internal Medicine, Hanyang University Guri Hospital, Guri , Korea
  • 2Department of Internal Medicine, Hanyang University Hospital, Seoul , Korea
  • 3Department of Clinical Pharmacology, Sungkyunkwan University, Seoul , Korea
  • 4Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon , Korea
  • 5Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan , Korea
  • 6Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul , Korea
  • 7Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju , Korea
  • 8Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul , Korea
  • 9Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul , Korea
  • 10Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul , Korea
  • 11Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon , Korea
  • 12Department of Internal Medicine, Eulji University School of Medicine, Seoul, Korea

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.

Keyword

Chronic hepatitis C; Vitamin D; Sustained virologic response
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