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. 2016 Nov 7;2016(11):CD010690. doi: 10.1002/14651858.CD010690.pub2

Sagheb 2012.

Methods
  • Study design: 4‐arm parallel RCT

  • Study duration: March 2008 to February 2009

  • Study follow‐up period: 8 weeks

Participants
  • Country: Iran

  • Setting: HD centre

  • Health status: chronic stable adult HD patients with RLS diagnosed using IRLSSG questionnaire

  • Number: treatment group 1 (15); treatment group 2 (15); treatment group 3 (15); control group (15)

  • Mean age ± SD (years): treatment group 1 (47.4 ± 14.2); treatment group 2 (54.6 ± 15.2); treatment group 3 (49.3 ± 12.9); control group (59.5 ± 17.9)

  • Sex (M/F): treatment group 1 (6/9); treatment group 2 (6/9); treatment group 3 (4/11); control group (9/6)

  • Exclusion criteria: participants receiving medications known to aggravate RLS such as tricyclic antidepressants, selective serotonin reuptake inhibitors, dopamine antagonists, dopamine blocking antiemetics, lithium, and sedative antihistamines; history of kidney stones were excluded due to concerns over increased risk of oxalosis and its joint and vascular complications in HD patients who consume vitamin C

Interventions Treatment group 1
  • Vitamin C 200 mg + Vitamin E 400 mg for 8 weeks


Treatment group 2
  • Vitamin C 200 mg + placebo for 8 weeks


Treatment group 3
  • Vitamin E 400 mg + placebo for 8 weeks


Control group
  • Placebo for 8 weeks


Co‐interventions
  • None

Outcomes
  • Severity of RLS at 0 and 8 weeks and the change in the score using IRLSG scoring system (0 to 40 max)

  • Adverse events

Notes
  • Funding source: grant from the Shiraz University of Medical Sciences, Shiraz, Iran

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Blocked randomisation with a fixed block size of four by randomisation sequence generator
Allocation concealment (selection bias) Low risk 1:1:1:1 random assignment to the 4 groups; this was done by an investigator who had no clinical involvement in the study
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double blind
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Double blind
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Used random sequence generating software
Selective reporting (reporting bias) Low risk Clear reporting of side effects. Study protocol clear enough from the methods section
Other bias Low risk Funded by a Grant from the Shiraz University of Medical Sciences, Shiraz, Iran