Pilz 2016.
Study characteristics | ||
Methods | Randomised clinical trial with parallel‐group design (2 groups) | |
Participants | 36 participants (25% women), aged 18 to 75 years, mean age 61 years, with liver cirrhosis Inclusion criteria: compensated cirrhosis, 25‐hydroxyvitamin D < 30 ng/mL, aged 18 to 75 years, and a negative pregnancy test in women of childbearing potential Exclusion criteria: presence of hepatocellular carcinoma, hypercalcaemia (plasma calcium concentrations > 2.65 mmol/L), pregnant or lactating women, drug intake as part of another clinical study, estimated glomerular filtration rate according to Modification of Diet in Renal Disease formula < 15 mL/min/1.73 m2, any clinically significant acute disease requiring drug treatment, regular intake (in addition to study medication) of vitamin D > 800 IU daily during the last 4 weeks before study entry |
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Interventions |
Intervention: vitamin D3 2800 IU/day (Oleovit D3, Fresenius Kabi, Austria) (n = 18) Control: placebo daily (n = 18) For 8 weeks |
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Outcomes |
Primary outcome: vitamin D status Secondary outcomes: liver function tests (i.e. AST, ALT, gamma glutamyl transpeptidase, and alkaline phosphatase), albumin, international normalised ratio, bilirubin, and hyaluronic acid; and parameters of mineral metabolism (i.e. parathyroid hormone, total plasma calcium, free plasma calcium, urinary midstream calcium to creatinine ratio, and plasma phosphate) |
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Stated aim of study | To evaluate the effects of vitamin D supplementation on 25‐hydroxyvitamin D, parameters of liver function and synthesis, and hyaluronic acid as a marker of liver fibrosis | |
Notes | “No patient died during the study and there was no excess of adverse events in the vitamin D group.” Study sponsored by the Medical University of Graz, Austria. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generation performed using computer random number generation. |
Allocation concealment (selection bias) | Low risk | Participant allocations could not have been foreseen in advance of, or during, enrolment. Central and independent randomisation unit controlled allocation. Investigators were unaware of allocation sequence. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and key study personnel ensured, and it is unlikely that blinding could have been broken. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of outcome assessment ensured, and it is unlikely that blinding could have been broken. |
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) | Low risk | All predefined outcomes reported. |
Other bias | Unclear risk | Trial may or may not have been free of other factors that could put it at risk of bias, such as small‐trial bias. |