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      Low‐protein diet for conservative management of chronic kidney disease: a systematic review and meta‐analysis of controlled trials

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          Abstract

          Background

          Recent data pose the question whether conservative management of chronic kidney disease (CKD) by means of a low‐protein diet can be a safe and effective means to avoid or defer transition to dialysis therapy without causing protein‐energy wasting or cachexia. We aimed to systematically review and meta‐analyse the controlled clinical trials with adequate participants in each trial, providing rigorous contemporary evidence of the impact of a low‐protein diet in the management of uraemia and its complications in patients with CKD.

          Methods

          We searched MEDLINE (PubMed) and other sources for controlled trials on CKD to compare clinical management of CKD patients under various levels of dietary protein intake or to compare restricted protein intake with other interventions. Studies with similar patients, interventions, and outcomes were included in the meta‐analyses.

          Results

          We identified 16 controlled trials of low‐protein diet in CKD that met the stringent qualification criteria including having 30 or more participants. Compared with diets with protein intake of >0.8 g/kg/day, diets with restricted protein intake (<0.8 g/kg/day) were associated with higher serum bicarbonate levels, lower phosphorus levels, lower azotemia, lower rates of progression to end‐stage renal disease, and a trend towards lower rates of all‐cause death. In addition, very‐low‐protein diets (protein intake <0.4 g/kg/day) were associated with greater preservation of kidney function and reduction in the rate of progression to end‐stage renal disease. Safety and adherence to a low‐protein diet was not inferior to a normal protein diet, and there was no difference in the rate of malnutrition or protein‐energy wasting.

          Conclusions

          In this pooled analysis of moderate‐size controlled trials, a low‐protein diet appears to enhance the conservative management of non‐dialysis‐dependent CKD and may be considered as a potential option for CKD patients who wish to avoid or defer dialysis initiation and to slow down the progression of CKD, while the risk of protein‐energy wasting and cachexia remains minimal.

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          Most cited references32

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          An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database

          Sophie AM Billingham, Amy Whitehead, Steven A Julious (2013)
          Background There is little published guidance as to the sample size required for a pilot or feasibility trial despite the fact that a sample size justification is a key element in the design of a trial. A sample size justification should give the minimum number of participants needed in order to meet the objectives of the trial. This paper seeks to describe the target sample sizes set for pilot and feasibility randomised controlled trials, currently running within the United Kingdom. Methods Data were gathered from the United Kingdom Clinical Research Network (UKCRN) database using the search terms ‘pilot’ and ‘feasibility’. From this search 513 studies were assessed for eligibility of which 79 met the inclusion criteria. Where the data summary on the UKCRN Database was incomplete, data were also gathered from: the International Standardised Randomised Controlled Trial Number (ISRCTN) register; the clinicaltrials.gov website and the website of the funders. For 62 of the trials, it was necessary to contact members of the research team by email to ensure completeness. Results Of the 79 trials analysed, 50 (63.3%) were labelled as pilot trials, 25 (31.6%) feasibility and 14 were described as both pilot and feasibility trials. The majority had two arms (n = 68, 86.1%) and the two most common endpoints were continuous (n = 45, 57.0%) and dichotomous (n = 31, 39.2%). Pilot trials were found to have a smaller sample size per arm (median = 30, range = 8 to 114 participants) than feasibility trials (median = 36, range = 10 to 300 participants). By type of endpoint, across feasibility and pilot trials, the median sample size per arm was 36 (range = 10 to 300 participants) for trials with a dichotomous endpoint and 30 (range = 8 to 114 participants) for trials with a continuous endpoint. Publicly funded pilot trials appear to be larger than industry funded pilot trials: median sample sizes of 33 (range = 15 to 114 participants) and 25 (range = 8 to 100 participants) respectively. Conclusion All studies should have a sample size justification. Not all studies however need to have a sample size calculation. For pilot and feasibility trials, while a sample size justification is important, a formal sample size calculation may not be appropriate. The results in this paper describe the observed sample sizes in feasibility and pilot randomised controlled trials on the UKCRN Database.
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            Functional status of elderly adults before and after initiation of dialysis.

            Manjula Kurella Tamura, Kenneth E. Covinsky, Glenn Chertow … (2009)
            It is unclear whether functional status before dialysis is maintained after the initiation of this therapy in elderly patients with end-stage renal disease (ESRD). Using a national registry of patients undergoing dialysis, which was linked to a national registry of nursing home residents, we identified all 3702 nursing home residents in the United States who were starting treatment with dialysis between June 1998 and October 2000 and for whom at least one measurement of functional status was available before the initiation of dialysis. Functional status was measured by assessing the degree of dependence in seven activities of daily living (on the Minimum Data Set-Activities of Daily Living [MDS-ADL] scale of 0 to 28 points, with higher scores indicating greater functional difficulty). The median MDS-ADL score increased from 12 during the 3 months before the initiation of dialysis to 16 during the 3 months after the initiation of dialysis. Three months after the initiation of dialysis, functional status had been maintained in 39% of nursing home residents, but by 12 months after the initiation of dialysis, 58% had died and predialysis functional status had been maintained in only 13%. In a random-effects model, the initiation of dialysis was associated with a sharp decline in functional status, indicated by an increase of 2.8 points in the MDS-ADL score (95% confidence interval [CI], 2.5 to 3.0); this decline was independent of age, sex, race, and functional-status trajectory before the initiation of dialysis. The decline in functional status associated with the initiation of dialysis remained substantial (1.7 points; 95% CI, 1.4 to 2.1), even after adjustment for the presence or absence of an accelerated functional decline during the 3-month period before the initiation of dialysis. Among nursing home residents with ESRD, the initiation of dialysis is associated with a substantial and sustained decline in functional status. 2009 Massachusetts Medical Society
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              A randomized, controlled trial of early versus late initiation of dialysis.

              Bruce A Cooper, Pauline Branley, Liliana Bulfone … (2010)
              In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease. We randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (GFR) between 10.0 and 15.0 ml per minute per 1.73 m2 of body-surface area (calculated with the use of the Cockcroft-Gault equation) to planned initiation of dialysis when the estimated GFR was 10.0 to 14.0 ml per minute (early start) or when the estimated GFR was 5.0 to 7.0 ml per minute (late start). The primary outcome was death from any cause. Between July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60 to 2.23) in the early-start group and 7.40 months (95% CI, 6.23 to 8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the estimated GFR was above the target of 7.0 ml per minute, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83 to 1.30; P=0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis). In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Funded by the National Health and Medical Research Council of Australia and others; Australian New Zealand Clinical Trials Registry number, 12609000266268.)
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                Author and article information

                Contributors
                Kamyar Kalantar‐Zadeh: kkz@uci.edu
                Journal
                Journal ID (nlm-ta): J Cachexia Sarcopenia Muscle
                Journal ID (iso-abbrev): J Cachexia Sarcopenia Muscle
                Journal ID (doi): 10.1007/13539.2190-6009
                Journal ID (publisher-id): JCSM
                Title: Journal of Cachexia, Sarcopenia and Muscle
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 2190-5991
                ISSN (Electronic): 2190-6009
                Publication date (Electronic): 02 November 2017
                Publication date (Print): April 2018
                Volume: 9
                Issue: 2 ( doiID: 10.1002/jcsm.v9.2 )
                Pages: 235-245
                Affiliations
                [ 1 ] Harold Simmons Center for Kidney Disease Research and Epidemiology, Division of Nephrology and Hypertension University of California Irvine Medical Center Orange CA USA
                [ 2 ] Department of Medicine University of California Irvine Health Orange CA USA
                [ 3 ] Division of Nephrology University of Tennessee Health Science Center Memphis TN USA
                [ 4 ] Memphis Veterans Affairs Medical Center Memphis TN USA
                [ 5 ] Tibor Rubin Veterans Affairs Long Beach Healthcare System Long Beach CA USA
                [ 6 ] Department of Epidemiology UCLA Fielding School of Public Health Los Angeles CA USA
                [ 7 ] Los Angeles Biomedical Research Institute at Harbor‐UCLA Torrance CA USA
                Author notes
                [*] [* ]Correspondence to: Kamyar Kalantar‐Zadeh, Harold Simmons Center for Kidney Disease Research and Epidemiology, Division of Nephrology and Hypertension, University of California Irvine Medical Center, 101 The City Drive South, City Tower, Orange, CA 92868‐3217, USA. Tel: (714) 456‐5142; Fax: (714) 456‐6034; Email: kkz@ 123456uci.edu
                [†]

                C. M. R. and S.‐F. Ahmadi contributed equally to this work.

                Article
                Publisher ID: JCSM12264 Other ID: JCSM-D-16-00174
                DOI: 10.1002/jcsm.12264
                PMC ID: 5879959
                PubMed ID: 29094800
                SO-VID: 3ab81a17-3075-40c1-b48b-d887b84582ed
                Copyright © © 2017 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of the Society on Sarcopenia, Cachexia and Wasting Disorders
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                Date received : 16 August 2016
                Date revision received : 08 October 2017
                Date accepted : 10 October 2017
                Page count
                Figures: 3, Tables: 2, Pages: 11, Words: 3372
                Categories
                Subject: Original Article
                Subject: Original Articles
                Custom metadata
                source-schema-version-number 2.0
                component-id jcsm12264
                cover-date April 2018
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.3.4 mode:remove_FC converted:02.04.2018

                ScienceOpen disciplines: Orthopedics
                Keywords: low‐protein diet,chronic kidney disease,glomerular filtration rate,end‐stage renal disease,all‐cause death,conservative management,cachexia,protein‐energy wasting
                Data availability:
                ScienceOpen disciplines: Orthopedics
                Keywords: low‐protein diet, chronic kidney disease, glomerular filtration rate, end‐stage renal disease, all‐cause death, conservative management, cachexia, protein‐energy wasting

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