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. 2019 Jan 4;2019(1):CD007834. doi: 10.1002/14651858.CD007834.pub3

Sloand 2004.

Methods Randomised, placebo‐controlled trial
Participants 25 adult men and women with ESRD (on either haemodialysis or peritoneal dialysis) who also had RLS by IRLSSG criteria, recruited from the dialysis units of a single medical centre (USA)
Interventions Active: IV iron dextran given as: 30 mg test dose over 3 min, followed by 970 mg (in 485 mL volume) over 3 hrs if no reaction to the test dose
Placebo: sodium chloride given in the same volume and with the same timing as the intervention group
Outcomes ferritin, hematocrit, gastrointestinal side effects, University of Rochester severity score (10‐point scale, where 0 = none, 10 = bad) at 0, 1, 2, 4 weeks
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not specified
Allocation concealment (selection bias) Low risk Randomisation appears to have been performed by pharmacy
Blinding (performance bias and detection bias) 
 All outcomes Low risk Medication and tubing covered with opaque sleeve to conceal treatment condition
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Two placebo participants dropped out after infusion; Figure 1 reports data on all 14 placebo participants although use of last observation carried forward not explicitly stated
Selective reporting (reporting bias) Unclear risk No study protocol available
Other bias Unclear risk Baseline imbalance of 2 points in RLS severity score; there was also a broader range of scores in the treated group; imbalance in duration of dialysis