Tags

Type your tag names separated by a space and hit enter

No additional benefit of prescribing a very low-protein diet in patients with advanced chronic kidney disease under regular nephrology care: a pragmatic, randomized, controlled trial.
Am J Clin Nutr. 2022 05 01; 115(5):1404-1417.AJ

Abstract

BACKGROUND

Whether a very low-protein diet supplemented with ketoanalogues (sVLPD), compared with a standard low-protein diet (LPD), improves outcomes in patients with chronic kidney disease (CKD) under stable nephrology care is undefined.

OBJECTIVES

To compare the effectiveness of sVLPD compared with LPD in patients regularly seen in tertiary nephrology care.

METHODS

Participants were patients with CKD stages 4-5, followed for at least 6 mo, randomly allocated to receive sVLPD or LPD [0.35 or 0.60 g/kg ideal body weight (IBW)/d, respectively], stratified by center and CKD stage. The primary outcome was time to renal death, defined as the first event between end-stage renal disease (ESRD) and all-cause mortality; secondary outcomes were the single components of the primary outcome, cardiovascular outcome, and nutritional status.

RESULTS

We analyzed 223 patients (sVLPD, n = 107; LPD, n = 116). Mean age was 64 y, 61% were male, and 35% had diabetes. Median protein intake (PI), which was 0.8 g/kg IBW/d at baseline in both groups, was 0.83 and 0.60 g/kg IBW/d in LPD and sVLPD, respectively, during the trial with a large decrease only in sVLPD (P = 0.011). During a median of 74.2 mo, we recorded 180 renal deaths (141 dialysis and 39 deaths before dialysis). Risk of renal death did not differ in sVLPD compared with LPD (HR: 1.17; 95% CI: 0.88, 1.57; P = 0.28). No difference was observed for ESRD (HR: 1.12; 95% CI: 0.81, 1.56; P = 0.51), mortality (HR: 0.95; 95% CI: 0.62, 1.45; P = 0.82), or time to fatal/nonfatal cardiovascular events (P = 0.2, log-rank test). After 36 mo, still active patients were 45 in sVLPD and 56 in LPD. No change of nutritional status emerged during the study in any arm.

CONCLUSIONS

This long-term pragmatic trial found that in patients with CKD under stable nephrology care, adherence to protein restriction is low. Prescribing sVLPD compared with standard LPD is safe but does not provide additional advantage to the kidney or patient survival.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Bellizzi V
Division of Nephrology, University Hospital "San Giovanni di Dio e Ruggi d'Aragona," Salerno, Italy.
Signoriello S
Medical Statistics Unit, University of Campania "Luigi Vanvitelli," Naples, Italy.
Minutolo R
Division of Nephrology, University of Campania "Luigi Vanvitelli," Naples, Italy.
Di Iorio B
Nephrology Unit, Moscati Hospital, Avellino, Italy.
Nazzaro P
Nephrology Unit, Cardarelli Hospital, Campobasso, Italy.
Garofalo C
Division of Nephrology, University of Campania "Luigi Vanvitelli," Naples, Italy.
Calella P
Division of Nephrology, University Hospital "San Giovanni di Dio e Ruggi d'Aragona," Salerno, Italy.
Chiodini P
Medical Statistics Unit, University of Campania "Luigi Vanvitelli," Naples, Italy.
De Nicola L
Division of Nephrology, University of Campania "Luigi Vanvitelli," Naples, Italy.
ERIKA Study Group Investigators of the Italian Society of Nephrology-Conservative Therapy of CKD Work Group
No affiliation info available

MeSH

Diet, Protein-RestrictedDisease ProgressionFemaleHumansKidney Failure, ChronicMaleMiddle AgedNephrologyRenal DialysisRenal Insufficiency, Chronic

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

34967847

Citation

Bellizzi, Vincenzo, et al. "No Additional Benefit of Prescribing a Very Low-protein Diet in Patients With Advanced Chronic Kidney Disease Under Regular Nephrology Care: a Pragmatic, Randomized, Controlled Trial." The American Journal of Clinical Nutrition, vol. 115, no. 5, 2022, pp. 1404-1417.
Bellizzi V, Signoriello S, Minutolo R, et al. No additional benefit of prescribing a very low-protein diet in patients with advanced chronic kidney disease under regular nephrology care: a pragmatic, randomized, controlled trial. Am J Clin Nutr. 2022;115(5):1404-1417.
Bellizzi, V., Signoriello, S., Minutolo, R., Di Iorio, B., Nazzaro, P., Garofalo, C., Calella, P., Chiodini, P., & De Nicola, L. (2022). No additional benefit of prescribing a very low-protein diet in patients with advanced chronic kidney disease under regular nephrology care: a pragmatic, randomized, controlled trial. The American Journal of Clinical Nutrition, 115(5), 1404-1417. https://doi.org/10.1093/ajcn/nqab417
Bellizzi V, et al. No Additional Benefit of Prescribing a Very Low-protein Diet in Patients With Advanced Chronic Kidney Disease Under Regular Nephrology Care: a Pragmatic, Randomized, Controlled Trial. Am J Clin Nutr. 2022 05 1;115(5):1404-1417. PubMed PMID: 34967847.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - No additional benefit of prescribing a very low-protein diet in patients with advanced chronic kidney disease under regular nephrology care: a pragmatic, randomized, controlled trial. AU - Bellizzi,Vincenzo, AU - Signoriello,Simona, AU - Minutolo,Roberto, AU - Di Iorio,Biagio, AU - Nazzaro,Paola, AU - Garofalo,Carlo, AU - Calella,Patrizia, AU - Chiodini,Paolo, AU - De Nicola,Luca, AU - ,, PY - 2021/05/25/received PY - 2021/12/20/accepted PY - 2021/12/31/pubmed PY - 2022/5/10/medline PY - 2021/12/30/entrez KW - CKD KW - ESRD KW - body composition KW - chronic kidney disease KW - ketoanalogues KW - low protein diet KW - nutrition KW - randomized controlled trials KW - renal death KW - renal diet SP - 1404 EP - 1417 JF - The American journal of clinical nutrition JO - Am J Clin Nutr VL - 115 IS - 5 N2 - BACKGROUND: Whether a very low-protein diet supplemented with ketoanalogues (sVLPD), compared with a standard low-protein diet (LPD), improves outcomes in patients with chronic kidney disease (CKD) under stable nephrology care is undefined. OBJECTIVES: To compare the effectiveness of sVLPD compared with LPD in patients regularly seen in tertiary nephrology care. METHODS: Participants were patients with CKD stages 4-5, followed for at least 6 mo, randomly allocated to receive sVLPD or LPD [0.35 or 0.60 g/kg ideal body weight (IBW)/d, respectively], stratified by center and CKD stage. The primary outcome was time to renal death, defined as the first event between end-stage renal disease (ESRD) and all-cause mortality; secondary outcomes were the single components of the primary outcome, cardiovascular outcome, and nutritional status. RESULTS: We analyzed 223 patients (sVLPD, n = 107; LPD, n = 116). Mean age was 64 y, 61% were male, and 35% had diabetes. Median protein intake (PI), which was 0.8 g/kg IBW/d at baseline in both groups, was 0.83 and 0.60 g/kg IBW/d in LPD and sVLPD, respectively, during the trial with a large decrease only in sVLPD (P = 0.011). During a median of 74.2 mo, we recorded 180 renal deaths (141 dialysis and 39 deaths before dialysis). Risk of renal death did not differ in sVLPD compared with LPD (HR: 1.17; 95% CI: 0.88, 1.57; P = 0.28). No difference was observed for ESRD (HR: 1.12; 95% CI: 0.81, 1.56; P = 0.51), mortality (HR: 0.95; 95% CI: 0.62, 1.45; P = 0.82), or time to fatal/nonfatal cardiovascular events (P = 0.2, log-rank test). After 36 mo, still active patients were 45 in sVLPD and 56 in LPD. No change of nutritional status emerged during the study in any arm. CONCLUSIONS: This long-term pragmatic trial found that in patients with CKD under stable nephrology care, adherence to protein restriction is low. Prescribing sVLPD compared with standard LPD is safe but does not provide additional advantage to the kidney or patient survival. SN - 1938-3207 UR - https://www.unboundmedicine.com/medline/citation/34967847/No_additional_benefit_of_prescribing_a_very_low_protein_diet_in_patients_with_advanced_chronic_kidney_disease_under_regular_nephrology_care:_a_pragmatic_randomized_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -