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

Watson 1988.

Methods
  • Study design: parallel RCT

  • Time frame: 1985 to 1988

  • Follow‐up period: 6 months

  • Lost to follow‐up: All completed study

Participants
  • Country: Canada

  • Setting: Single centre

  • Starting CAPD; minimal or no renal bone disease on X‐ray

  • Number: treatment group (6); control group (6)

  • Mean age ± SD (years): treatment (11.6 ± 6.0); control group (16.4 ± 14.0)

  • Sex (M/F): treatment group (4/2); control group (4/2)

  • Exclusion criteria: severe radiological or evidence of clinical bone disease

Interventions Treatment group
  • 1α‐hydroxyvitamin D 10‐20 ng/kg/d for 6 months


Control group
  • Standard CAPD treatment only


Co‐interventions
  • Phosphate binders; vitamins B and C supplements

Outcomes
  • Bone histology

  • Serum Ca, phosphorus, ALP, PTH and aluminium levels

  • Bone X‐rays

  • Number with hypercalcaemia

Notes
  • Median derived radiological scores provided in graphical form only

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Low risk Randomly allocated by sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding and lack of blinding could influence patient management
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Laboratory results and bone histology assessed by investigator unaware of treatment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients completed study
Selective reporting (reporting bias) Low risk All relevant outcomes reported
Other bias High risk Supported by Leo laboratories

AKI ‐ acute kidney injury; ALP ‐ alkaline phosphatase; AKI ‐ acute kidney injury; BMD ‐ bone mineral density; Ca ‐ serum calcium; Ca x P ‐ calcium‐phosphorus product; CAPD ‐ continuous ambulatory peritoneal dialysis; CCPD ‐ continuous cycling peritoneal dialysis; CKD ‐ chronic kidney disease; CrCl ‐ creatinine clearance; DHT ‐ dihydrotachysterol; eGFR ‐ estimated glomerular filtration rate; HD ‐ haemodialysis; HVSDS ‐ height velocity standard deviation score; IP ‐ intraperitoneal; IV ‐ intravenous; K ‐ serum potassium; M/F ‐ male/female; PD ‐ peritoneal dialysis; PTH ‐ parathyroid hormone; SLE ‐ systemic lupus erythrocytosis; RCT ‐ randomised controlled trial; rhGH ‐ growth hormone; RRT ‐ renal replacement therapy; SDS ‐ standard deviation score