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Cited by 263Dialysis and Renal Disease ManagementClinical Nutrition and GastroenterologyChronic Kidney Disease and Diabetes

Efficacy and Safety of a Very-Low-Protein Diet When Postponing Dialysis in the Elderly: A Prospective Randomized Multicenter Controlled Study

Brunori, Giuliano, Viola, Battista F., Parrinello, Giovanni, De Biase, Vincenzo, Como, Giovanna, Franco, Vincenzo, Garibotto, Giacomo, Zubani, Roberto +1 more·2007·American Journal of Kidney Diseases
DOI 10.1053/j.ajkd.2007.02.278
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Abstract

Background A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy. Study design Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis. Setting & participants Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s). Intervention Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms. Outcomes & measurements Mortality, hospitalization, and metabolic markers. Results 56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was -3.6% (95% CI, -17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01). Limitations The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment. Conclusion An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.

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  • An Italian RCT of older (>70 years) CKD patients close to starting dialysis showed that a very low protein diet (0.3 g/kg BW/d) supplemented with keto-analogues, amino acids, and vitamins delayed the start of dialysis by approximately 11 months compared with a control group on a nonrestricted protein diet.

    “An Italian RCT of older (!70 years) patients with CKD who were close to starting dialysis 117 showed that a very low protein diet with 0.3 g/kg BW/d, supplemented with keto-analogues, amino acids, and vitamins, delayed the start of dialysis by approximately 11 months compared with a control group who followed a nonrestricted protein diet and immediately started dialysis.”

    From Evidence-Based Recommendations for Optimal Dietary Protein Intake in Older People: A Position Paper From the PROT-AGE Study Group (2013) · cites this paper as [117]

  • In that Italian RCT, patients prescribed a very low protein diet had similar mortality rates and maintained nutritional status compared with the control group.

    “Compared with the control group, patients who were prescribed a very low protein diet had similar mortality rates and their nutritional status was maintained.”

    From Evidence-Based Recommendations for Optimal Dietary Protein Intake in Older People: A Position Paper From the PROT-AGE Study Group (2013) · cites this paper as [117]

  • In the Italian RCT, patients enrolled were not malnourished at baseline and received nutritional counseling and follow-up nutritional care to maintain intake at 35 kcal/kg BW/d.

    “It is important to mention that patients enrolled in the study were not malnourished at baseline, and that they received nutritional counseling and follow-up nutritional care to maintain intake at 35 kcal/kg BW/d.”

    From Evidence-Based Recommendations for Optimal Dietary Protein Intake in Older People: A Position Paper From the PROT-AGE Study Group (2013) · cites this paper as [117]

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Authors
Brunori, G., Viola, B. F., Parrinello, G., De Biase, V., Como, G., Franco, V., Garibotto, G., Zubani, R., & Cancarini, G. C.
Affiliations
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
  • University of Brescia (IT)
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
  • Santa Maria Nuova Hospital (IT)
  • University of Genoa (IT)
Corresponding author
Brunori, Giuliano
ORCID
Venue
American Journal of Kidney Diseases
Publisher
Elsevier BV
Published
2007-05
Volume
49
Issue
5
Pages
569-580
ISSN
0272-6386 (ISSN-L)
DOI
10.1053/j.ajkd.2007.02.278
OpenAlex
W1993837538
Cited by
263
References
44
Citations by year
2026: 5 · 2025: 17 · 2024: 7 · 2023: 14 · 2022: 8 · 2021: 15 · 2020: 13 · 2019: 11 · 2018: 22 · 2017: 14 · 2016: 13 · 2015: 8 · 2014: 21 · 2013: 21 · 2012: 14
FWCI
9.72
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • American Journal of Kidney Diseases (publishedVersion)
  • PubMed (publishedVersion)
  • Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
  • CINECA IRIS Institutial Research Information System (University of Genoa) (submittedVersion)
Topics
  • Health Sciences › Medicine › Nephrology › Dialysis and Renal Disease Management
  • Health Sciences › Nursing › Nutrition and Dietetics › Clinical Nutrition and Gastroenterology
  • Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
Keywords
very low protein diet, end-stage renal disease, elderly patients, uremia, non-inferiority, one-year mortality, hospitalization, hyperkalemia, fluid overload, malnutrition, vegan diet, amino acid supplementation, vitamin supplementation, metabolic biomarkers, dialysis initiation timing
MeSH terms
Aged, Aged, 80 and over, Female, Follow-Up Studies, Renal Dialysis, Humans, Kidney Failure, Chronic, Male, Prospective Studies, Time Factors, Survival Rate, Diet, Protein-Restricted

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