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. 2018 Oct 4;2018(10):CD001892. doi: 10.1002/14651858.CD001892.pub4

Ihle 1989.

Methods
  • Study design: parallel RCT

  • Duration of study: not reported

  • Study follow‐up period: 18 months

Participants
  • Country: Australia

  • Setting: single centre, outpatient department

  • Patients with stable SCr 350 to 1000 µmol/L for 3 months before enrolment; CKD stage: 4‐5

  • Number (randomised/analysed): very low protein diet group (34/31); normal protein diet group (38/33)

  • Mean age ± SD (years): very low protein diet group (37.2. ± 5.7); normal protein diet group (36.8 ± 4.8)

  • Sex (M/F): very low protein diet group (22/9); normal protein diet group (21/12)

  • Exclusion criteria: potentially reversible kidney dysfunction; systemic disease (diabetes, connective tissue disorders); medications that could alter course of disease (immunosuppressive agents, ACEi)

Interventions Very low protein diet group
  • Prescribed protein intake: 0.4 g protein/kg/d


Normal protein diet group
  • Prescribed protein intake: > 0.75 g/kg/d


Both groups received 35 to 40 kcal/kg/d
Co‐interventions
  • Not reported

Outcomes
  • ESKD: SCr > 1300 µmol/L or uraemic symptoms requiring dialysis

  • Decline in GFR over time (measured by Cr‐51 EDTA clearance)

  • Body weight

Notes
  • Three participants withdrew voluntarily; 5 excluded for not complying with medication or dietary regimen

  • Data from 64 evaluated participants included

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded and lack of blinding may influence patient management
Blinding of outcome assessment (detection bias): End or change in GFR 
 End of change in GFR Low risk Primary outcome was laboratory measurement of GFR by EDTA clearance and unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias): Need to start dialysis 
 Need to start dialysis High risk Decision to commence dialysis depending on uraemic symptoms and/or SCr > 1300 µmol/L
Incomplete outcome data (attrition bias) 
 All outcomes High risk 8/72 (11%) excluded from analyses (3 withdrew; 5 excluded for non‐compliance with diet)
Selective reporting (reporting bias) High risk Report on number reaching ESKD & GFR. Body weight only reported graphically. Deaths not reported but there appear to be no deaths
Other bias Unclear risk Insufficient information to permit judgement