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. 2019 Oct 22;2019(10):CD005015. doi: 10.1002/14651858.CD005015.pub4

El‐Agroudy 2003a.

Methods
  • Study design: parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 12 months

Participants
  • Country: Egypt

  • Setting: single centre

  • Inclusion criteria: males aged > 20 years; not diabetic, no steroids prior to transplantation; not on HD > 2 years

  • Number: treatment group (20); control group (20)

  • Mean age ± SD (years): treatment group (31.4 ± 10.1); control group (31.6 ± 10.7)

  • Sex (M/F): all male

  • Exclusion criteria: impaired graft function (SCr > 0.18 mmol/L); prior fracture; hypogonadism; adrenal gland diseases

Interventions Treatment group
  • Alfacalcidol: 0.5 mg/d


Control group
  • No treatment


Co‐interventions
  • Calcium

Outcomes
  • Kidney function tests, serum calcium and phosphorus

  • BMD of lumbar spine, femoral neck, and forearm by DEXA

Notes
  • Funding source: not reported

  • Trial registration: not applicable as published before end of 2005

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated sequence
Allocation concealment (selection bias) Low risk Randomised treatment allocation was concealed in sequentially numbered and sealed opaque envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Single‐blind
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients completed 1 year of the study
Selective reporting (reporting bias) Low risk Patient‐centred outcomes captured and reported systematically
Other bias Unclear risk No additional threats to validity identified