Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study
- 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.
- All Author(s)
- J. Y. Jeong
; D. W. Jun
; S. J. Park
; J. H. Sohn
; S. G. Kim
; S. W. Lee
; S. W. Jeong
; M. Y. Kim
; W. Kim
; J. J. Shim
; J.-J. Shim
; H. S. Kim
; K. T. Suk
; S. B. Ahn
- Issued Date
- 2020
- Type
- Article
- Keyword
- Chronic hepatitis C; Vitamin D; Sustained virologic response
- Publisher
- 대한내과학회
Korean Association of Internal Medicine
- ISSN
- 1226-3303
; 2005-6648
- Citation Title
- The Korean journal of internal medicine
- Citation Volume
- 35
- Citation Number
- 5
- Citation Start Page
- 1074
- Citation End Page
- 1083
- Language(ISO)
- eng
- DOI
- 10.3904/kjim.2018.273
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/3236
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