Xing 2013.
Methods | Randomised clinical trial with parallel group design (3 groups). | |
Participants | 75 participants (17% women), aged 28 to 65 years, mean age 48 years, undergoing liver transplantation. Inclusion criteria: primary liver transplant recipients. Exclusion criteria: history of corticosteroid, anticonvulsant, or vitamin D intake; renal disease. |
|
Interventions |
Intervention 1: calcitriol 0.25 μg/day + calcium gluconate (n = 25). Intervention 2: calcium gluconate (n = 25). Control: placebo (n = 25). For 1 month. |
|
Outcomes | Outcomes reported in abstract of publication: Primary outcomes: acute cellular rejection rate at 1 month' post transplant. Secondary outcomes: none stated. |
|
Stated aim of study | To investigate effects of calcitriol on acute cellular rejection rate of liver transplant recipients. | |
Notes | Study sponsored by a grant from Shanghai Nature Science Fund project and a grant from Science and Technology Department of Shanghai. Additional information received through personal communication with the authors on 13 February 2014. | |
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 allocation not described so that intervention allocations may have been foreseen in advance of, or during, enrolment. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk'. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk'. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data 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 | Low risk | Trial appeared to be free of industry sponsorship or other type of for‐profit support that could manipulate the trial design, conductance, or trial results. |
Other bias | Low risk | Trial appeared to be free of other factors that could put it at risk of bias. |