Sloand 2004.

Methods	Study design: parallel RCT Study duration: not reported Study follow‐up period: 4 weeks
Participants	Country: USA Setting: dialysis centre in Rochester, USA Health status: stable adult HD and PD (3 in placebo group) diagnosed with RLS; concurrent medications used to treat RLS were not discontinued or tapered, but new medications, including oral iron, could not be added within 1 month before entry into this study and the dosage of medications used to treat RLS could not be changed within this period or during the study Number: treatment group (11); control group (14) Mean age ± SD (years): treatment group (55.8 ± 11); control group (54.3 ± 3.7) Sex (M/F): treatment group (6/5); control group (10/4) Exclusion criteria: childbearing potential; severe liver disease; polycythaemia or evidence for haemochromatosis; a history of 10 or more blood transfusions during the 2 years before the study; history of hypersensitivity to IV iron; receipt of any IV iron within 1 month of enrolment; weight < 50 kg; URR < 65% (unless kinetic modelling using Kt/V was > 1.2); a change in dialysis prescription within 3 months of entry; fistula recirculation > 12%; active inflammatory or rheumatologic disease
Interventions	Treatment group IV iron dextran 1000 mg IV diluted in 500 mL on dialysis (administered only once during the study period) Control group 500 mL of normal saline infused during dialysis (administered only once during the study period) Both placebo and drug were infused during dialysis by infusion pump with the medication (or placebo) and tubing covered with an opaque obscuring sleeve so that neither the patient, investigator, nor study nurse could detect which was being administered
Outcomes	RLS severity assessed by a non‐validated questionnaire at 0, 1, 2, 4 weeks (scores range from 0 to 10) Multiple other lab parameters such as haemoglobin, iron stores were measured Adverse events
Notes	Funding source not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No clear mention of the randomisation process
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Both placebo and drug were infused during dialysis by infusion pump with the medication (or placebo) and tubing covered with an opaque obscuring sleeve so that neither the patient, investigator, nor study nurse could detect which was being administered
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Patients were blinded to the treatment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome data available
Selective reporting (reporting bias)	Low risk	Protocol not available but published report contained expected outcome (Improvement in RLS severity) Side effects were also reported
Other bias	Unclear risk	Funding source not reported