Shiomi 1999b.

Study characteristics
Methods	Randomised clinical trial with parallel‐group design (2 groups)
Participants	34 women, aged 36 to 72 years, mean age 56 years, with primary biliary cirrhosis Inclusion criteria: primary biliary cirrhosis Exclusion criteria: none stated
Interventions	Intervention: calcitriol 0.5 μg twice a day (n = 17) Control: no intervention (n = 17) For 1 year
Outcomes	Outcomes reported in abstract of publication Primary outcome: bone mineral density Secondary outcomes: none stated
Stated aim of study	To evaluate the efficacy of calcitriol (1,25‐dihydroxyvitamin D) in the treatment of bone disease associated with primary biliary cirrhosis
Notes	All participants completed the trial. Additional information received through personal communication with authors on 12 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	High risk	No blinding, and outcome is likely to have been influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of outcome assessment, and outcome measurement is likely to have been 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)	High risk	Not all predefined outcomes reported in full.
Other bias	Unclear risk	Trial may or may not have been free of other components that could put it at risk of bias, such as competing interest bias.