title: Ketoanalogue-Supplemented Vegetarian Very Low-Protein Diet and CKD Progression.
abstract: Dietary protein restriction may improve determinants of CKD progression. However, the extent of improvement and effect of ketoanalogue supplementation are unclear. We conducted a prospective, randomized, controlled trial of safety and efficacy of ketoanalogue-supplemented vegetarian very low-protein diet (KD) compared with conventional low-protein diet (LPD). Primary end point was RRT initiation or >50% reduction in initial eGFR. Nondiabetic adults with stable eGFR<30 ml/min per 1.73 m(2), proteinuria <1 g/g urinary creatinine, good nutritional status, and good diet compliance entered a run-in phase on LPD. After 3 months, compliant patients were randomized to KD (0.3 g/kg vegetable proteins and 1 cps/5 kg ketoanalogues per day) or continue LPD (0.6 g/kg per day) for 15 months. Only 14% of screened patients patients were randomized, with no differences between groups. Adjusted numbers needed to treat (NNTs; 95% confidence interval) to avoid composite primary end point in intention to treat and per-protocol analyses in one patient were 4.4 (4.2 to 5.1) and 4.0 (3.9 to 4.4), respectively, for patients with eGFR<30 ml/min per 1.73 m(2) Adjusted NNT (95% confidence interval) to avoid dialysis was 22.4 (21.5 to 25.1) for patients with eGFR<30 ml/min per 1.73 m(2) but decreased to 2.7 (2.6 to 3.1) for patients with eGFR<20 ml/min per 1.73 m(2) in intention to treat analysis. Correction of metabolic abnormalities occurred only with KD. Compliance to diet was good, with no changes in nutritional parameters and no adverse reactions. Thus, this KD seems nutritionally safe and could defer dialysis initiation in some patients with CKD.
authors.affiliation: Department of Nephrology and Internal Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania; and Department of Nephrology, "Dr. Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania lilianagarna@yahoo.com.
authors.forename: Liliana
authors.initials: L
authors.lastname: Garneata
authors.affiliation: Department of Nephrology, "Dr. Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Stancu
authors.affiliation: Department of Nephrology, "Dr. Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania.
authors.forename: Diana
authors.initials: D
authors.lastname: Dragomir
authors.affiliation: Department of Nephrology and Internal Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania; and Department of Nephrology, "Dr. Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Stefan
authors.affiliation: Department of Nephrology and Internal Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania; and Department of Nephrology, "Dr. Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Mircescu
mesh_terms: D000601:Amino Acids, Essential / Q000627:therapeutic use*; D018753:Diet, Protein-Restricted; D014676:Diet, Vegetarian; D019587:Dietary Supplements; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D051436:Renal Insufficiency, Chronic / Q000178:diet therapy*
chemical_list: D000601:Amino Acids, Essential; C048995:ketosteril
keywords: nutrition; phosphate binders; progression of chronic renal failure; renal function decline
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