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. 2015 Nov 12;2015(11):CD008327. doi: 10.1002/14651858.CD008327.pub2

Hodson 1985.

Methods
  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up period: 12 months (0.6 to 1.2 years)

  • Loss to follow‐up/excluded: probably 37% (9/24); unclear but only 15 included in analysis

Participants
  • Country: Australia

  • Setting: Single centre

  • CKD including dialysis; documented bone disease on histology

  • Number (randomised/analysed): treatment group (13/8); control group (11/7)

  • Age: not reported

  • Sex (M/F): 14/10

  • Exclusion criteria: not reported

Interventions Treatment group
  • Calcitriol: 15 ng/kg/d for 12 months, increased till Ca reached 2.6. Final dose 5 to 30 ng/kg/d


Control group
  • Ergocalciferol: 0.25 mg/d for 12 months, increased till serum Ca reached 2.6 Final dose 25 to 100 µg/kg/d


Co‐interventions
  • Dialysis (9); bicarbonate supplements; aluminium‐containing phosphate binders

Outcomes
  • Bone histology

  • Bone radiology, bone age

  • Growth cm/y: % expected for bone age

  • Biochemistry: PTH, ALP, Ca, P

Notes
  • Number of exclusions unclear. Reported that 6/24 excluded (4 calcitriol, 2 ergocalciferol) but only 15/24 analysed so 9/24 excluded

  • Only patients undergoing pre and post biopsies were included

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Systematic ranking design in blocks of 4 based on severity of bone histology changes
Allocation concealment (selection bias) High risk Investigators aware of blocks so could influence next entry
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No Blinding. Lack of blinding could influence patient management
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Laboratory based outcomes
Incomplete outcome data (attrition bias) 
 All outcomes High risk 9/24 (38%) excluded from final analysis
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Low risk No evidence of other bias