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

Chauveau 1986.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up period: 12 months

Participants
  • Country: France

  • Setting: Single centre

  • Patients with good general medical condition; motivated to take low protein diet; CrCl 5 to 15 mL/min/1.73 m2; SCr > 500 µmol/L in females and > 600 µmol/L in males; declining kidney function over 3 months

  • Number: very low protein diet group (10); low protein diet group (9)

  • Mean age ± SD (years): very low protein diet group (66.3 ± 6); low protein diet group (55.6 ± 10.5)

  • Sex M/F: very low protein diet group (5/5); low protein diet group (2/7)

  • Exclusion criteria: kidney disease due to diabetes; systemic disease; nephrotic syndrome; proteinuria > 3 g/d; unstable obstructive uropathy; unable to attend monthly follow‐up; GI tract disorders; Not motivated to take low protein diet

Interventions Very low protein diet group
  • Prescribed protein intake: 0.4 g protein/kg/d + oral supplement with keto acids (1 tab Ketosteril /6 kg BW/d)

  • Calculated protein intake: 0.5 g/kg/d


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

  • Calculated protein intake: 0.7 g/kg/d


Both groups had calorie intake of 35 to 40 Kcal/kg/d
Co‐interventions
  • Bicarbonate supplements, iron and water soluble vitamins

  • Vitamin D and phosphate binders

  • Treatment for hypertension

Outcomes
  • 1/serum creatinine against time

  • CrCl

  • Compliance with diet

  • Commencement of dialysis

  • Death (all causes)

Notes
  • Withdrawal from therapy if poor adherence or intolerance to keto acids or to the low protein diet, uraemic symptoms, or evidence of under‐nutrition, serum urea > 50 mmol/L and/or SCr > 1200 μmol/L

  • 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 (1/Cr or CrCl) was laboratory based and unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias): Need to start dialysis 
 Need to start dialysis Low risk Decision to commence dialysis made by dialysis staff independently of study investigators
Incomplete outcome data (attrition bias) 
 All outcomes High risk 26% (5/19) excluded from analysis of 1/Cr but information on dialysis available for all
Selective reporting (reporting bias) Low risk Reported on dialysis, death, body weight, GFR measure reported
Other bias Unclear risk Insufficient information to permit judgement