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

Schmitt 2003.

Methods

  • Study design: RCT; data from a subset of prepubertal participants with GFR < 40 mL/min/1.73 m2 included in Ardissino 2000

  • Time frame: 1998 to 2003

  • Follow‐up period: 12 months

  • Loss to follow‐up/excluded post randomisation: 17% (5/29)
Participants

  • Country: Europe

  • Setting: International, multicentre study

  • eGFR < 40 mL/min/1.73 m2; PTH > 70 pg/mL

  • Number (randomised/analysed): treatment group (14/12); control group (15/12)

  • Mean age, range (years): treatment group (5.5, 2.4 to 8.4); control group (5.1, 1.4 to 9.1)

  • Sex (M/F): treatment group (11/1); control group (10/2)

  • Exclusion criteria: Ca < 8.5 mg/dL or > 11.5 mg/dL; P < 3.8 mg/dL or > 7.5 mg/dL; underlying serious disease; rhGH or corticosteroids treatment; dialysis
Interventions Treatment group

  • Intermittent oral calcitriol 35 ng/kg twice weekly for 12 month. After 1 month dose adjusted for PTH level


Control group

  • Daily oral calcitriol 10 ng/kg for 12 months. After 1 month dose adjusted for PTH levels


Co‐interventions

  • Phosphate binders and other medications according to clinical requirements
Outcomes

  • Change in height SDS

  • Average time integrated mean plasma PTH; % maximal fall in mean PTH levels; number with reduced PTH levels

  • Change in estimated CrCl

  • Change in median ALP levels

  • Serum Ca x P; number with hypercalcaemia or hyperphosphataemia
Notes

  • Serum Ca x P shown graphically only
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Centrally randomised according to PTH levels
Allocation concealment (selection bias) Low risk Centrally randomised according to PTH levels
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded and lack of blinding could influence patient management
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk not blinded but lack of blinding unlikely to influence patient management
Incomplete outcome data (attrition bias) 
 All outcomes High risk 5/29 (17%) left study (RRT 4, rhGH 1). Could have influenced results
Selective reporting (reporting bias) Low risk Data reported on all expected outcomes
Other bias Low risk No evidence of other bias