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

Wissing 2005.

Methods
  • Study design: open‐label, parallel RCT

  • Duration of study: January 1999 to August 2000

  • Duration of follow‐up: 12 months

Participants
  • Country: Belgium

  • Setting: single centre

  • Inclusion criteria: all patients receiving a kidney transplant

  • Number: treatment group (38); control group (41)

  • Mean age ± SD (years): treatment group (43.0 ± 12.3); control group (42.7 ± 14.8)

  • Sex (M/F): treatment group (23/15); control group (22/19)

  • Exclusion criteria: hypercalcaemia; graft loss; unwillingness to provide informed consent

Interventions Treatment group
  • Cholecalciferol (oral): 25,000 IU/month 12 months


Control group
  • No treatment


Co‐interventions
  • Calcium carbonate or calcium acetate

Outcomes
  • Hypercalcaemia (equal or greater than 2.4 mmol/L)

  • BMD at lumbar spine and femoral neck

  • Acute graft rejection

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) High risk Alternate allocation
Allocation concealment (selection bias) High risk Alternate allocation
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Unblinded study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 11/90 participants lost to follow‐up
Selective reporting (reporting bias) High risk Patient‐centred outcomes not reported systematically
Other bias Unclear risk No additional threats to validity identified

ACR ‐ albumin‐creatinine ratio; BMD ‐ bone mineral density; CNI ‐ calcineurin inhibitor/s; CrCl ‐ creatinine clearance; DEXA ‐ dual energy X‐ray absorptiometry; DGF ‐ delayed graft function; DM ‐ diabetes mellitus; (e)GFR ‐ (estimated) glomerular filtration rate; GI ‐ gastrointestinal; HD ‐ haemodialysis; HIV ‐ human immunodeficiency virus; M/F ‐ male/female; MMF ‐ mycophenolate mofetil; PRA ‐ panel reactive antibody; (i)PTH ‐ (intact) parathyroid hormone; RAAS ‐ renin‐angiotensin‐aldosterone system; RAS ‐ renin‐angiotensin system; RCT ‐ randomised controlled trial; SC ‐ subcutaneous; SCr ‐ SCr; SD ‐ standard deviation; UACR ‐ urinary albumin:creatinine ratio; UPCR ‐ urinary protein:creatinine ratio