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COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Effectiveness of renal-specific oral nutritional supplements compared with diet counseling in malnourished hemodialysis patients.
International Urology and Nephrology 2021 August
BACKGROUND: Malnutrition is highly prevalent and a consequence of inflammation and related comorbidities among patients on maintenance hemodialysis. Oral nutritional supplementation (ONS) is recommended for malnourished patients with kidney failure. The study aimed to evaluate renal-specific oral nutrition (ONCE dialyze) supplement on nutritional status in patients on hemodialysis.
METHODS: Patients were randomized into 3 groups; treatment groups received 370 kcal/day of ONCE Dialyze (N = 26) or 370 kcal/day of NEPRO (N = 30) for 30 days. The control group (N = 24) received no intervention. All patients were counseled by the same registered dietitian during the study. The nutritional status was evaluated using malnutrition inflammation score (MIS) assessment, body compositions, serum albumin and pre-albumin levels at baseline and 30 days.
RESULTS: Eighty patients were analyzed with mean age of 57.2 ± 15.9 years. The intervention group exhibited significant improvements in energy, protein, fat, fiber and magnesium intake by dietary interview compared with the control group. Percentage of changes in MIS was - 29.0% (95% CI - 40.5 to - 17.4), - 23.9% (95% CI - 37.2 to - 10.6) and 12.1% (95% CI - 19.2 to 43.4) for the ONCE dialyze, NEPRO and control groups, respectively (overall P = 0.006). Percentage of changes in serum albumin was 5.3% (95% CI 1.9-8.7), 3.3% (95% CI - 0.1 to 6.7) and - 0.8% (95% CI - 4.3 to 2.7) for the ONCE dialyze, NEPRO, and control groups, respectively (overall P = 0.039; P = 0.043 for ONCE dialyze vs. control). No serious adverse effects were reported in any group.
CONCLUSION: Dietary advice combined with ONS especially ONCE dialyze was associated with improved MIS, serum albumin, dietary energy and macronutrient intake among patients with kidney failure on maintenance hemodialysis.
CLINICAL TRIAL REGISTRATION: TCTR20200801001.
METHODS: Patients were randomized into 3 groups; treatment groups received 370 kcal/day of ONCE Dialyze (N = 26) or 370 kcal/day of NEPRO (N = 30) for 30 days. The control group (N = 24) received no intervention. All patients were counseled by the same registered dietitian during the study. The nutritional status was evaluated using malnutrition inflammation score (MIS) assessment, body compositions, serum albumin and pre-albumin levels at baseline and 30 days.
RESULTS: Eighty patients were analyzed with mean age of 57.2 ± 15.9 years. The intervention group exhibited significant improvements in energy, protein, fat, fiber and magnesium intake by dietary interview compared with the control group. Percentage of changes in MIS was - 29.0% (95% CI - 40.5 to - 17.4), - 23.9% (95% CI - 37.2 to - 10.6) and 12.1% (95% CI - 19.2 to 43.4) for the ONCE dialyze, NEPRO and control groups, respectively (overall P = 0.006). Percentage of changes in serum albumin was 5.3% (95% CI 1.9-8.7), 3.3% (95% CI - 0.1 to 6.7) and - 0.8% (95% CI - 4.3 to 2.7) for the ONCE dialyze, NEPRO, and control groups, respectively (overall P = 0.039; P = 0.043 for ONCE dialyze vs. control). No serious adverse effects were reported in any group.
CONCLUSION: Dietary advice combined with ONS especially ONCE dialyze was associated with improved MIS, serum albumin, dietary energy and macronutrient intake among patients with kidney failure on maintenance hemodialysis.
CLINICAL TRIAL REGISTRATION: TCTR20200801001.
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