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

Eke 1983.

Methods
  • Study design: parallel RCT

  • Time frame: 1981 to 1983

  • Follow‐up period: 12 months

  • Loss to follow‐up/excluded: 6% (1/16)

Participants
  • Country: UK

  • Setting: single centre

  • GFR 20 to 50 mL/min/1.73 m2

  • Number: treatment group (8); control group (8)

  • Mean age: 10.4 years

  • Sex (M/F): not reported

  • Exclusion criteria: previously treated with vitamin D or its analogues

Interventions Treatment group
  • Oral 1α‐hydroxyvitamin D: 10 ng/kg/d for 1 year


Control group
  • Oral calciferol: 670 ng/kg/d for 1 year


Co‐interventions
  • Aluminium hydroxide as phosphate binder

Outcomes
  • Change in GFR measured by 51Cr EDTA

  • Bone histology, BMD

  • X‐ray changes

  • Ca, phosphorus, ALP

  • Number with hypercalcaemia

Notes
  • Graphical data only for changes in GFR, Ca, phosphorus and PTH

  • No clear numerical data for BMD, X‐rays, ALP

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Said to be "double‐blind" study but no other information provided
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Said to be double‐blind but no other information provided
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcomes are laboratory based and unlikely to be influenced by blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk One patient excluded when commenced RRT but this unlikely to influence results
Selective reporting (reporting bias) High risk No reporting of actual numbers for outcomes of GFR, PTH and other biochemistry
Other bias Low risk Leo Laboratories provided medications