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

NCT01418508.

Trial name or title Effects of Low Protein Diet Supplemented Keto‐/Amino Acid in Preventing the Progression of Chronic Kidney Disease (CKD) (ELPD Study)
Methods
  • Parallel RCT

Participants Inclusion criteria
  • Patients aged 18 to 75 years with CKD stage 3b and 4 (15 mL/min/1.73 m2 < GFR < 45 mL/min/1.73 m2, estimated by EPI formula) receiving conservative treatment for CKD


Exclusion criteria
  • DM

  • Incapable of following study requirements to control diet

  • GFR < 15 mL/min/1.73 m2

  • Hypercalcaemia or hyperkalaemia (> normal upper limit)

  • Other serious disease (heart, lung, brain) within the last 3 months

  • Cardiac failure stage IV NYHA

Interventions
  • Low protein diet plus alpha‐keto acid 0.6 g protein/kg/d

  • Very low protein diet plus alpha‐keto acid 0.3 g protein/kg/d

Outcomes
  • Changes in GFR (1 year)

  • Compliance to diet

  • Quality of life (1 year)

  • Cardiovascular death

  • Nutritional status defined by anthropo‐plicometry, biochemistry, body bioimpedance analysis, subjective global nutritional assessment

Starting date August 2011
Contact information Xuemei Li, M.D.& Ph.D. 8610‐65295058 0605.mei@gmail.com, Limeng Chen, M.D.& Ph.D. 8610‐65295351 climeng2000@yahoo.com.c
Notes Investigators contacted but no reply received

CKD ‐ chronic kidney disease; DM ‐ diabetes mellitus; GFR ‐ glomerular filtration rate; NYHA ‐ New York Heart Association; RCT ‐ randomised controlled trial