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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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Project description:Background: Muscle wasting, observed in patients with end-stage kidney disease and protein energy wasting (PEW), is associated with increased mortality for those on hemodialysis (HD). Oral nutritional supplementation (ONS) and nutrition counseling (NC) are treatment options for PEW but research targeting muscle status, as an outcome metric, is limited. Aim: We compared the effects of combined treatment (ONS + NC) vs. NC alone on muscle status and nutritional parameters in HD patients with PEW. Methods: This multi-center randomized, open label-controlled trial, registered under ClinicalTrials.gov (Identifier no. NCT04789031), recruited 56 HD patients identified with PEW using the International Society of Renal Nutrition and Metabolism criteria. Patients were randomly allocated to intervention (ONS + NC, n = 29) and control (NC, n = 27) groups. The ONS + NC received commercial renal-specific ONS providing 475 kcal and 21.7 g of protein daily for 6 months. Both groups also received standard NC during the study period. Differences in quadriceps muscle status assessed using ultrasound (US) imaging, arm muscle area and circumference, bio-impedance spectroscopy (BIS), and handgrip strength (HGS) methods were analyzed using the generalized linear model for repeated measures. Results: Muscle indices as per US metrics indicated significance (p < 0.001) for group × time interaction only in the ONS + NC group, with increases by 8.3 and 7.7% for quadriceps muscle thickness and 4.5% for cross-sectional area (all p < 0.05). This effect was not observed for arm muscle area and circumference, BIS metrics and HGS in both the groups. ONS + NC compared to NC demonstrated increased dry weight (p = 0.039), mid-thigh girth (p = 0.004), serum prealbumin (p = 0.005), normalized protein catabolic rate (p = 0.025), and dietary intakes (p < 0.001), along with lower malnutrition-inflammation score (MIS) (p = 0.041). At the end of the study, lesser patients in the ONS + NC group were diagnosed with PEW (24.1%, p = 0.008) as they had achieved dietary adequacy with ONS provision. Conclusion: Combination of ONS with NC was effective in treating PEW and contributed to a gain in the muscle status as assessed by the US, suggesting that the treatment for PEW requires nutritional optimization via ONS.

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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