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

Malvy 1999.

Methods
  • Study design: parallel RCT

  • Study duration: January 1983 to May 1987

  • Study follow‐up period: 3 to 35 months

Participants
  • Country: France

  • Setting: multicentre (two sites)

  • Patients with CKD with GFR < 19 mL/min/1.73 m2 (calculated by Cockcroft formula)

  • Number: very low protein diet group (25); low protein diet group (25)

  • Mean age ± SD (years): very low protein diet group (53.8 ± 11); low protein diet group (56.0 ± 14)

  • Sex (M/F): very low protein diet group (14/11); low protein diet group (15/10)

  • Exclusion criteria: DM; cancer; systemic disease; obstructive uropathy; RPGN; lethal disease

Interventions Very low protein diet group
  • Protein intake: 0.3 g protein/kg/d

  • Oral keto acid supplement (Ketosteril 1 tab/6 kg/d): 0.17 g/kg/d

  • Calculated protein intake: 0.58 g/kg/d


Low protein diet group
  • Protein intake: 0.6 g protein/kg/d

  • Calculated protein intake: 0.79 g/kg/d


Co‐interventions
  • Vitamin supplements, antihypertensive medications

Outcomes
  • ESKD: CrCl < 5 mL/min/1.73 m2 or uraemic intolerance diagnosed by two nephrologists and requiring dialysis

  • Weight, lean body mass, fat body mass

  • Death (all causes)

Notes
  • Information on numbers reaching ESKD provided by Dr Bagros

  • 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 of CrCl based on laboratory outcome so unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias): Need to start dialysis 
 Need to start dialysis Low risk GFR < 5 mL/min/1.73 m2 estimated from (CrCl + urea clearance)/2 or uraemic symptoms requiring dialysis as determined by 2 nephrologists
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear whether all participants included in outcome measurement
Selective reporting (reporting bias) High risk Numbers reaching GFR endpoint only available graphically
Other bias Unclear risk Insufficient information to permit judgement