Methods |
Study design: parallel RCT
Time frame: 2001 to 2003
Follow‐up period: 12 weeks after 2 to 6 weeks washout
Loss to follow‐up: 17 did not complete study but included in analysis 0% (0/29)
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Participants |
Country: USA
Setting: national, multicentre
HD for at least 1 month; PTH ≥ 300 pg/mL; Ca ≤ 10.5 mg/L, Ca x P ≤ 70 after 2 to 6 weeks run‐in
Number (randomised/completed): treatment group (15/10); control group (14/2)
Mean age ± SD (years): treatment group (13.6 ± 4.76); control group (14.3 ± 4.15)
Sex (M/F): treatment group (13/2); control group (5/9)
Exclusion criteria: allergy to paricalcitol or other vitamin D; pregnant; nursing; other major illness; AKI in previous 3 months; partial parathyroidectomy in previous 12 months; aluminium binders in past 3 months or likely to need binders; poor compliance; drugs likely to affect bone metabolism
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Interventions |
Treatment group
IV paricalcitol: (0.04 µg/kg if PTH ≤ 500, and 0.08 µg/kg if PTH ≥ 500) 3 times/week for 12 weeks
Dose altered according to Ca and P levels
Control group
Co‐interventions
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Outcomes |
Proportion with > 30% fall in PTH on 2 consecutive occasions
Mean change in PTH levels
Mean changes in serum Ca, phosphorus, Ca x P levels
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Central randomisation |
Allocation concealment (selection bias) |
Low risk |
Central randomisation |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Placebo and active medication given IV after dialysis |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Placebo and active medication given IV after dialysis; Primary outcome was laboratory based |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
12 (41%) prematurely withdrawn (5 treatment; 10 placebo) but these patients included in evaluation of primary outcome |
Selective reporting (reporting bias) |
Low risk |
All relevant laboratory outcomes are included |
Other bias |
High risk |
Supported by Abbott Laboratories |