Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study
- Author:
Jae Yoon JEONG
1
;
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
Author Information
- Publication Type:ORIGINAL ARTICLE
- From:The Korean Journal of Internal Medicine 2020;35(5):1074-1083
- CountryRepublic of 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 adverseeffects 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.
