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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-? (PEG-IFN-?) 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-? plus RBV (control group) or PEG-IFN-? 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-? plus RBV and 77 patients received the PEG-IFN-? 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.

SUBMITTER: Jeong JY

PROVIDER: S-EPMC7487303 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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

Jeong Jae Yoon JY Jun Dae Won DW Park Sol Ji SJ Sohn Joo Hyun JH Kim Sang Gyune SG Lee Se Whan SW Jeong Soung Won SW Kim Moon Young MY Kim Won W Shim Jae-Jun JJ Kim Hyoung Su HS Suk Ki Tae KT Ahn Sang Bong SB

The Korean journal of internal medicine 20191112 5

<h4>Background/aims</h4>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).<h4>Methods</h4>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 ...[more]

PMID: 31710801

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Dataset Information

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

Publications

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

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