Yokoyama 2014.
Methods | Randomised clinical trial with parallel group design (2 groups). | |
Participants | 84 participants (49% women), aged 30 to 78 years, mean age 59 years, with HCV genotype 1b. Inclusion criteria: aged ≥ 20 years, chronically infected with HCV genotype 1 and plasma HCV RNA concentrations ≥ 100 log IU/mL. Exclusion criteria: decompensated cirrhosis, liver cancer, HBV or HIV infection, renal insufficiency, history of heart disease or cerebral infarction, pregnancy or breastfeeding. |
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Interventions |
Intervention: subcutaneous injections of PEG‐IFN‐α‐2b (1.5 μg/kg body weight) once weekly, along with weight‐based oral ribavirin (600 mg/day to 1200 mg/day) + vitamin D3 1000 IU (n = 42). Control: subcutaneous injections of PEG‐IFN‐α‐2b (1.5 μg/kg body weight) once weekly, along with weight‐based oral ribavirin (600 mg/day to 1200 mg/day) (n = 42). For 16 weeks. |
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Outcomes |
Primary outcome: undetectable HCV RNA at week 24. Secondary outcomes: none stated. |
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Stated aim of study | To rigorously evaluate the antiviral effects of vitamin D supplementation in people with HCV genotype‐1 infection being treated with PEG‐IFN + ribavirin. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not specified. |
Allocation concealment (selection bias) | Unclear risk | Method used to conceal the allocation not described so intervention allocations may have been foreseen before, or during, enrolment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding, and outcome was likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment, and outcome measurement was likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data were unlikely to make treatment effects depart from plausible values. |
Selective reporting (reporting bias) | Unclear risk | Unclear whether all predefined and clinically relevant and reasonably expected outcomes were reported. |
For‐profit bias | Unclear risk | Trial may or may not have been free of for‐profit bias as trial did not provide any information on clinical trial support or sponsorship. |
Other bias | Low risk | Trial appeared to be free of other factors that could put it at risk of bias. |
ALT: alanine aminotransferase; AST: aspartate aminotransferase; BMI: body mass index; EVR: early viral response; HBV: hepatitis B virus; HCV: hepatitis C virus; HDV: hepatitis D virus; IFN: interferon; IU: international unit; MRI: magnetic resonance imaging; n: number of participants; NAFLD: non‐alcoholic fatty liver disease; PCR: polymerase chain reaction; PEG: pegylated; RNA: ribonucleic acid; RVR: rapid viral response; SVR: sustained virological response; US: ultrasound; WBC: white blood cell count.