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. 2012 Oct 17;2012(10):CD008176. doi: 10.1002/14651858.CD008176.pub2

SPACE Study 2000.

Methods
  • Study design: Parallel RCT

  • Time frame: NS

Participants Inclusion criteria
  • Setting: multicentre (6 centres)

  • Country: Israel

  • Stable haemodialysis patients

  • Number: treatment group (97); control group (99)

  • Age: treatment group (64.9 ± 8.3); control group (64.4 ± 8.8)

  • Sex (M/F): treatment group (67/30); control group (68/31)


Exclusion criteria
  • Anticoagulant therapy with warfarin sodium; known history of malignant disease; active liver disease; treatment with hypolipidemic agents for less than 8 weeks before study commencement

Interventions
  • Treatment group

    • Vitamin E (natural ɑ‐tocopherol) provided as 2 capsules of 400 IU each to be taken nightly

  • Control group

    • Matching placebo

Outcomes
  • Cardiovascular disease

  • Fatal and non‐fatal myocardial infarction

  • Cardiovascular‐disease mortality

  • All‐cause mortality

  • Ischaemic stroke

  • Peripheral vascular disease

  • Unstable angina

  • Adverse events

  • Cancer

Notes Mean duration of follow‐up: 1.4 years
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated coin toss, each participating centre randomised separately
Allocation concealment (selection bias) Unclear risk No information regarding methods to prevent allocation concealment
Blinding (performance bias and detection bias) 
 All outcomes Low risk Study reported the used of double blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes of all initially randomised patients were reported (although the use of intention‐to‐treat analyses was not explicitly stated in the methods)
Selective reporting (reporting bias) Low risk Study protocol is not separately available, however, it appears all expected outcomes, including those that were pre‐specified, have been reported
Other bias Low risk Funding: This research was funded by grant 4204 from the Chief Scientist’s Office, Ministry of Health, Israel
Vitamin E provided by Solgar, Inc, New York, USA, during the first year and Henkel Corp, La Grange, IL, USA, during the second year.