Educación alimentaria en pacientes en dialisis / Nutritional education in dialysis patients

La enfermedad renal crónica terminal aumenta el riesgo cardiovascular y puede ocasionar defectos en la mineralización ósea. Para prevenir esto, se debe mantener el fósforo plasmático normal, que depende de la diálisis, los quelantes y la ingesta de fósforo, principalmente de origen inorgánico, incorporado mediante aditivos alimentarios. Las intervenciones nutricionales son pilares en el tratamiento de estos pacientes. El objetivo es facilitar estrategias alimentarias a un grupo de pacientes pediátricos en diálisis, mediante educación alimentaria nutricional, para aumentar el consumo de alimentos naturales, disminuyendo la ingesta de fósforo inorgánico especialmente de los productos cárnicos procesados. Materiales y métodos: se estudió una población pediátrica en diálisis. Se preparó un programa educativo con atención personalizada, instrucción alimentaria y seguimiento mensual, seguido de un taller. Resultados: n: 17 pacientes, edad decimal media de 12,3, 53% sexo masculino, 88% en hemodiálisis. Previo a la intervención el 64,7% consumía productos cárnicos procesados. Luego del taller el 58,8% disminuyó su consumo, el 41,2% aumentó la ingesta de preparaciones caseras, el 53% incorporó nuevos condimentos, de los cuales el 89% presentó al incorporarlos, mejor aceptación a las preparaciones. Conclusiones: la hiperfosfatemia está presente en alrededor del 50% de los pacientes en diálisis asociándose a un incremento entre 20% al 40% del riesgo de mortalidad. La presencia de fósforo oculto en los alimentos y la falta de adherencia hacen prioritario trabajar en programas educativos que favorezcan el aprendizaje colaborativo, centralizados en prácticas culinarias, para brindar herramientas que faciliten una alimentación natural, disminuyendo el consumo de ultraprocesados (AU)

Chronic end-stage renal disease increases the risk of cardiovascular disease and may lead to defects in bone mineralization. In order to prevent these risks, normal plasma phosphorus levels should be maintained. Achieving this goal depends on dialysis, chelators, and phosphorus intake, mainly of inorganic origin, incorporated through food supplements. Nutritional interventions are crucial in the treatment of these patients. The objective is to facilitate nutritional strategies to a group of pediatric dialysis patients, through food education, to increase the consumption of natural foods, decreasing the intake of inorganic phosphorus, especially from processed meat products. Materials and methods: a pediatric population undergoing dialysis was studied. An educational program was prepared with personalized care, nutritional instruction, and monthly follow-up visits, followed by a workshop. Results: n: 17 patients, mean age 12.3 years, 53% male, 88% on hemodialysis. Prior to the intervention, 64.7% consumed processed meat products. After the workshop, 58.8% decreased their consumption, 41.2% increased the intake of homemade food, 53% incorporated new seasonings, of whom 89% reported better acceptance of the preparations when they were incorporated. Conclusions: hyperphosphatemia is observed in around 50% of patients undergoing dialysis and is associated with a 20% to 40% increased risk of mortality. The presence of hidden phosphorus in food and the lack of adherence point to the need for the development of educational programs that promote collaborative learning, focusing on food-preparation practices. These programs should provide tools that facilitate a natural diet, reducing the consumption of ultra-processed food (AU)

Implementation and effectiveness of an intensive education program on phosphate control among hemodialysis patients: a non-randomized, single-arm, single-center trial.

BACKGROUND: Hyperphosphatemia is a common complication in patients on maintenance hemodialysis. Patients' adherence to phosphorus control can be improved by consistent education. However, few studies have focused on the model construction and effects of health education on phosphate control for hemodialysis patients. OBJECTIVE: To develop an intensive education program focusing on phosphate control among hemodialysis patients and to analyze the effectiveness of this program. DESIGN: A non-randomized, single-arm, single-center trial lasting for 6 months. SETTING: This program was conducted in a hemodialysis center in a teaching hospital in Zhuhai, China. PARTICIPANTS: Patients on maintenance hemodialysis with hyperphosphatemia. METHODS: An intensive hyperphosphatemia control education program lasting for 6 months was conducted among 366 hemodialysis patients applying the First Principles of Instruction model, which focused on mastering four stages: (a) activation of prior experience, (b) demonstration of skills, (c) application of skills and (d) integration of these skills into real-world activities. The controlled percentage of serum phosphorus, knowledge of hyperphosphatemia, and adherence to phosphate binders before and after the education program were assessed. RESULTS: The proportion of controlled serum phosphorus was significantly increased from 43.5 to 54.9% (P<0.001). The scores on the knowledge of phosphate control were improved significantly from 59.0 ± 18.9 to 80.6 ± 12.4 (P < 0.001). The proportion of high adherence to phosphate binders was increased dramatically from 21.9 to 44.5% (P < 0.001). CONCLUSION: The intensive education program can effectively improve serum phosphorus, knowledge of hyperphosphatemia, and adherence to phosphate binders among hemodialysis patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2100042017 . Retrospectively registered January 12th, 2021.

Optimal Phosphate Control Related to Coronary Artery Calcification in Dialysis Patients.

BACKGROUND: In patients on maintenance dialysis, cardiovascular mortality risk is remarkably high, which can be partly explained by severe coronary artery calcification (CAC). Hyperphosphatemia has been reported to be associated with the severity of CAC. However, the optimal phosphate range in patients on dialysis remains unknown. This study was planned to compare the effects on CAC progression of two types of noncalcium-based phosphate binders and of two different phosphate target ranges. METHODS: We conducted a randomized, open-label, multicenter, interventional trial with a two by two factorial design. A total of 160 adults on dialysis were enrolled and randomized to the sucroferric oxyhydroxide or lanthanum carbonate group, with the aim of reducing serum phosphate to two target levels (3.5-4.5 mg/dl in the strict group and 5.0-6.0 mg/dl in the standard group). The primary end point was percentage change in CAC scores during the 12-month treatment. RESULTS: The full analysis set included 115 patients. We observed no significant difference in percentage change in CAC scores between the lanthanum carbonate group and the sucroferric oxyhydroxide group. On the other hand, percentage change in CAC scores in the strict group (median of 8.52; interquartile range, -1.0-23.9) was significantly lower than that in the standard group (median of 21.8; interquartile range, 10.0-36.1; P=0.006). This effect was pronounced in older (aged 65-74 years) versus younger (aged 20-64 years) participants (P value for interaction =0.003). We observed a similar finding for the absolute change in CAC scores. CONCLUSIONS: Further study with a larger sample size is needed, but strict phosphate control shows promise for delaying progression of CAC in patients undergoing maintenance hemodialysis. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Evaluate the New Phosphate Iron-Based Binder Sucroferric Oxyhydroxide in Dialysis Patients with the Goal of Advancing the Practice of EBM (EPISODE), jRCTs051180048.

Route of intestinal absorption and tissue distribution of iron contained in the novel phosphate binder ferric citrate.

BACKGROUND: Anemia of chronic kidney disease (CKD) is, in part, caused by hepcidin-mediated impaired iron absorption. However, phosphate binder, ferric citrate (FC) overcomes the CKD-induced impairment of iron absorption and increases serum iron, transferrin saturation, and iron stores and reduces erythropoietin requirements in CKD/ESRD patients. The mechanism and sites of intestinal absorption of iron contained in FC were explored here. METHODS: Eight-week old rats were randomized to sham-operated or 5/6 nephrectomized (CKD) groups and fed either regular rat chow or rat chow containing 4% FC for 6 weeks. They were then euthanized, and tissues were processed for histological and biochemical analysis using Prussian blue staining, Western blot analysis to quantify intestinal epithelial tight junction proteins and real-time PCR to measure Fatty Acid receptors 2 (FFA2) and 3 (FFA3) expressions. RESULTS: CKD rats exhibited hypertension, anemia, azotemia, and hyperphosphatemia. FC-treated CKD rats showed significant reductions in blood pressure, serum urea, phosphate and creatinine levels and higher serum iron and blood hemoglobin levels. This was associated with marked increase in iron content of the epithelial and subepithelial wall of the descending colon and modest iron deposits in the proximal tubular epithelial cells of their remnant kidneys. No significant difference was found in hepatic tissue iron content between untreated and FC-treated CKD or control groups. Distal colon's epithelial tight Junction proteins, Occludin, JAM-1 and ZO-1 were markedly reduced in the CKD groups. The FFA2 expression in the jejunum and FFA3 expression in the distal colon were significantly reduced in the CKD rats and markedly increased with FC administration. CONCLUSION: Iron contained in the phosphate binder, FC, is absorbed by the distal colon of the CKD animals via disrupted colonic epithelial barrier and upregulation of short chain fatty acid transporters.

Multidisciplinary education approach to optimize phosphate control among hemodialysis patients.

Background Hyperphosphatemia is a common consequence in end stage renal disease. It is associated with increased cardiovascular risk and mortality, also development of hyperparathyroidism and mineral bone disease. A patient educational program involving physician, pharmacist and dietician was developed to manage hyperphosphatemia among hemodialysis patients. Objective To investigate the efficacy of the program in optimal phosphate control among hemodialysis patients. Setting Kuala Lipis Hospital, Malaysia. Method This was a non-randomized, single-arm community trial running for a period of 6 months. The program consisted of a small group seminar and individual counseling sessions. Two individual counseling sessions were conducted for each patient, focusing on diet and medication adherence, by an accredited dietician and pharmacist respectively. The group seminar was delivered by a multidisciplinary team involving a physician, pharmacist and dietician. Topics included basic knowledge of hyperphosphatemia, phosphate binder and dietary phosphate control. Eligible and consented patients had knowledge and medication adherence assessment, measurement of pre-dialysis serum calcium, albumin, phosphate, haemoglobin and alkaline phosphatase before and after the educational program. Main outcome measure Phosphate level, knowledge and medication adherence assessment. Results Fifty-seven patients completed the program and were included into final data analysis. The median (IQR) phosphate level (mmol/L) was 1.86 (1.45-2.24) before and decreased to 1.47 (1.21-1.91) and 1.49 (1.28-1.81) 3 months and 6 months after PEP (p < 0.001). The percentage of patients with uncontrolled phosphate level was reduced from 59.3 to 35.6% and 42.1% after the PEP (p = 0.003). The mean knowledge score almost doubled after the intervention, with a mean pre-score of 8.61 (95% CI 7.85-9.37) to mean post-score of 15.31 (95% CI 14.85-15.76). The adherence to phosphate binder also improved from 17.2 to 41.4% after PEP (p = 0.007). Conclusion A multidisciplinary patient education program is an effective approach to manage hyperphosphatemia among hemodialysis patients in Malaysia.

Cardiovascular Outcomes of Calcium-Free vs Calcium-Based Phosphate Binders in Patients 65 Years or Older With End-stage Renal Disease Requiring Hemodialysis.

Importance: Guidelines restricting use of calcium-based phosphate binders in all patients with end-stage renal disease owing to their potential contribution to increased cardiovascular risk shifted prescribing from calcium acetate toward the costlier sevelamer carbonate products. Objective: To compare cardiovascular events and mortality between patients with end-stage renal disease (ESRD) undergoing hemodialysis receiving sevelamer vs calcium acetate in real-world practice. Design, Setting, and Participants: An observational cohort study was conducted using the United States Renal Data System linked to Medicare claims data (May 1, 2012, to December 31, 2013). Data analysis was performed from October 2017 to September 2018. Participants included patients 65 years or older with ESRD within 180 days after starting hemodialysis (sevelamer, 2647; calcium acetate, 2074). Exposures: New use of sevelamer (calcium-free phosphate binder) vs calcium acetate (calcium-based phosphate binder). Main Outcomes and Measures: Hazard ratios (HRs) with 95% CIs were estimated for fatal or nonfatal cardiovascular events (myocardial infarction or ischemic stroke: primary outcome) and all-cause mortality (secondary outcome) using Cox proportional hazards regression with fine stratification on the propensity score to control for potential confounders, including phosphorus and calcium levels. Results: After propensity score weighting, 2639 patients initiating sevelamer treatment (1184 men [44.9%]; mean [SD] age, 75.6 [6.9] years) and 2065 patients initiating calcium acetate treatment (930 men [45.0%]; mean [SD] age, 75.5 [7.1] years) were included in the analysis. Crude incidence rates (IRs) for cardiovascular events of 458 per 1000 person-years for sevelamer and 464 per 1000 person-years for calcium acetate were observed. After propensity score fine-stratification weighting, HRs of 0.96 (95% CI, 0.84-1.10) for cardiovascular events were observed. Results were consistent within subgroups of age (<75 y: primary outcome, HR, 1.02; 95% CI, 0.85-1.24; vs ≥75 years: primary outcome, HR, 0.83; 95% CI, 0.69-1.01) and sex (primary outcome in men: HR, 1.02; 95% CI, 0.83-1.26). Conclusions and Relevance: The results of the study do not suggest increased cardiovascular safety of sevelamer in the routine clinical practice of patients with ESRD compared with calcium acetate; this study's findings suggest that well-designed, long-term, randomized clinical trials are needed.

Improvement in Hyperphosphatemia Using Phosphate Education and Planning Talks.

OBJECTIVE: Hyperphosphatemia is a common complication in patients with end-stage renal disease on hemodialysis. The mainstay of phosphate management involves a low-phosphate diet and use of phosphate binders, yet these are often insufficient. This study was the first to use behavioral change techniques to encourage the use of phosphate binders and dietary modifications through a series of Phosphate Education and Planning (PEP) talks. DESIGN AND METHODS: A total of 46 hemodialysis patients with hyperphosphatemia were enrolled. All patients were eligible to receive a series of 4 talks, each with defined goals of the long-term management of serum phosphate levels. Qualitative data from the talks were gathered during each intervention, whereas serum phosphate was selected as an outcome measure. RESULTS: There was a modest improvement (-0.31 mg/dL) in the serum phosphate levels of the patients who received the entire PEP talk series. Furthermore, the most common self-identified barriers for patients were phosphate binder prescriptions not tailored to their eating routines and lack of resources for suitable dietary changes. CONCLUSIONS: The PEP talk series model is appropriate to manage persistent hyperphosphatemia despite usual management in outpatient dialysis unit by identifying patient-specific barriers and providing resources that can mitigate them. The strength of this model lies in using a multifaceted approach by applying both pharmacotherapy and dietary changes, along with behavioral change, to achieve lasting improvements in serum phosphate levels in hemodialysis patients with persistently elevated serum phosphate levels.

A practical self-made device in parathyroid autotransplantation for patients with secondary hyperparathyroidism.

OBJECTIVE: Secondary hyperparathyroidism (sHPT) is one of the most serious complications in patients on long-term hemodialysis. These patients may suffer from metabolic bone diseases, severe atherosclerosis, and undesirable cardiovascular events. Endoscopic parathyroidectomy with autotransplantation is a treatment option for those who do not respond to clinical management. This study aimed to investigate practical use of a self-made device in parathyroid autotransplantation for patients with sHPT, and to compare this device with ordinary surgical scissors. METHODS: A total of 15 patients with sHPT were treated with endoscopic parathyroidectomy and autotransplantation. Pieces of parathyroid tissue were squeezed in our self-made device and injected into the brachioradialis muscle. Sixteen patients with sHPT who were treated with traditional parathyroid transplantation served as controls. Serum levels of parathyroid hormone, alkaline phosphatase, calcium, phosphorus and intact parathyroid hormone were measured before and after surgery. RESULTS: Preoperative symptoms were alleviated, and serum parathyroid hormone and alkaline phosphatase levels, hyperphosphatemia, and hypercalcemia were improved or normalized in all of the patients in both groups. Pathological examinations showed that parathyroid cells remained active. CONCLUSION: Application of our squeezing device is an economic, effective, and safe method in endoscopic parathyroidectomy and autotransplantation for patients with sHPT.

EPIC Trial: education programme impact on serum phosphorous control in CKD 5D patients on hemodialysis / Ensaio EPIC: impacto do programa de educação no controle de fósforo sérico em pacientes com DRC 5D em hemodiálise

Abstract Introduction: In stage 5D chronic kidney disease (CKD 5D) patients, the encouragement of treatment adherence by health professionals is a significant clinical challenge. Objectives: This study evaluates the impact of a nutritional education programme on hyperphosphatemia, utilizing the transtheoretical model of behavior change (TMBC). Subjects and Methods: A prospective interventional study comprising 179 CKD 5D patients with hypophosphatemia. The 4-month educational programme took place during dialysis sessions. Demographic and laboratory data were evaluated, whilst the TMBC was utilized both pre- and post-intervention. Results: 132 patients showed a positive change and significant reduction in phosphate levels, whilst 47 patients showed a negative change and little reduction in phosphate levels. Positive changes were identified at different levels of literacy. 117/179 participants had ongoing treatment with sevelamer throughout the trial period. 61 patients with intact parathyroid hormone (iPTH) < 300pg/ml showed phosphate level reductions, whilst 118 patients with iPTH > 300 pg/ml also showed a decrease in phosphate levels. Conclusions: Nutritional education programmes can achieve excellent results when appropriately applied. An education programme may be effective across different literacy levels.

Resumo Introdução: nos pacientes com insuficiência renal crônica no estágio 5D (DRC 5D), o incentivo à adesão ao tratamento pelos profissionais de saúde é um desafio clínico significativo. Objetivos: Este estudo avalia o impacto de um programa de educação nutricional em hiperfosfatemia, utilizando o modelo transteórico de mudança de comportamento (TMBC). Casuística e métodos: estudo prospectivo de intervenção que incluiu 179 pacientes com DRC 5D com hipofosfatemia. O programa educacional de 4 meses ocorreu durante as sessões de diálise. Os dados demográficos e laboratoriais foram avaliados, enquanto o TMBC foi utilizado tanto antes, quanto após a intervenção. Resultados: 132 pacientes apresentaram variação positiva e redução significativa nos níveis de fosfato, enquanto 47 pacientes apresentaram variação negativa e pouca redução nos níveis de fosfato. Mudanças positivas foram identificadas em diferentes níveis de alfabetização. 117/179 participantes foram submetidos a tratamento contínuo com sevelamer ao longo do estudo. Tivemos 61 pacientes com hormônio paratireoidiano intacto (iPTH) < 300 pg/ml que apresentaram redução do nível de fosfato, enquanto 118 pacientes com iPTH > 300 pg/ml também mostraram uma diminuição nos níveis de fosfato. Conclusões: os programas de educação nutricional podem produzir excelentes resultados quando adequadamente empregados. Um programa de educação pode ser efetivo em diferentes níveis de alfabetização.

Correlation of lanthanum dosage with lanthanum deposition in the gastroduodenal mucosa of dialysis patients.

Lanthanum (La) deposition has been observed in gastrointestinal mucosa of dialysis patients treated with La carbonate to treat hyperphosphatemia in the 6 years since its authorization in Japan. We investigated gastrointestinal biopsies from 112 dialysis patients, and found 15 cases of histiocytic aggregation with crystalloids and one case of duodenitis with histiocyte aggregation without crystalloids in the 30 patients treated with La carbonate. No histiocytic lesions were observed in the 82 patients without La carbonate administration. So far in total 70 cases of La deposition in the alimentary tract have been reported, including our 16 cases. Neither clinical nor histological findings other than histiocytic aggregation were specific in the patients with La deposition. We also compared the groups with and without La deposition, revealing that the daily and total doses of La carbonate showed statistically significant correlations with La deposition. However the causality with their histologic features, e.g. intestinal metaplasia and degree of inflammation, were inconclusive between the two groups. Although no critical symptoms have been reported, it is necessary to accumulate more cases to clarify the mechanism of La deposition, because dialysis patients must take phosphate buffers for a long period.

Intervenção educacional de enfermagem para redução da hiperfosfatemia em pacientes em hemodiálise / Intervención educativa de enfermería para reducir hiperfosfatemia en pacientes en hemodiálisis / Educational nursing intervention to reduce the hyperphosphatemia in patients on hemodialysis

RESUMO Objetivo: avaliar a efetividade de uma intervenção educacional de enfermagem para redução da hiperfosfatemia em pacientes renais crônicos em hemodiálise. Método: estudo quase experimental realizado com 63 pacientes hiperfosfatêmicos em hemodiálise. A intervenção se constituiu em orientar e disponibilizar um manual impresso e ilustrado aos pacientes, contendo informações sobre o controle da doença. Foi solicitado o preenchimento de um checklist diário, com finalidade recordatória dos aspectos abordados no manual. Os exames laboratoriais e a intensidade do prurido foram analisados no início do estudo, aos 30 e 60 dias após a intervenção educacional. Resultados: a média de idade dos participantes foi 58±13,1 anos e tempo de tratamento de 51,1±44,7 meses. Houve redução dos valores séricos do fósforo de 7,06±1,43 para 5,80±1,53 (p<0,001) e da intensidade do prurido após a intervenção. Conclusão: a Intervenção Educacional de Enfermagem foi efetiva para redução do fosfato e diminuição do prurido nos pacientes hiperfosfatêmicos.

RESUMEN Objetivo: evaluar la eficacia de una intervención educativa de enfermería para reducir hiperfosfatemia en pacientes con insuficiencia renal crónica en hemodiálisis. Método: estudio cuasi-experimental con 63 pacientes en hemodiálisis con hiperfosfatemia. La intervención consistió en guiar los pacientes y proporcionar un manual impreso e ilustrado con informaciones sobre el control de la enfermedad. Se solicitó completar una lista de verificación todos los días con el propósito de recordar los aspectos tratados en el manual. Se analizaron las pruebas de laboratorio y la intensidad del picor al inicio del estudio, 30 y 60 días después de la intervención educativa. Resultados: la edad promedio de los participantes fue 58±13,1 años y el tiempo de tratamiento fue 51,1±44,7 meses. Hubo reducción de los valores séricos de fósforo de 7,06±1,43 para 5,80±1,53 (p<0,001) y de la intensidad del picor después de la intervención. Conclusión: la intervención educativa de enfermería fue eficaz en la reducción de fosfato y disminución del picor en pacientes con hiperfosfatemia.

ABSTRACT Objective: to evaluate the effectiveness of an educational nursing intervention to reduce hyperphosphataemia in chronic renal patients on hemodialysis. Method: quasi-experimental study with 63 hyperphosphatemic patients on hemodialysis. The intervention consisted of developing and providing a printed and illustrated manual to patients containing information on disease control. The participant was asked to complete a daily checklist with the aim to reinforce aspects provided in the manual. Laboratory tests and itching intensity were analyzed at the beginning of the study, and at 30 and 60 days after the educational intervention. Results: the mean age of participants was 58±13.1 years, with a treatment time of 51.1±44.7 months. A reduction in serum phosphorus values of 7.06 ± 1.43 to 5.80 ± 1.53 (p <0.001) and the intensity of itching after the intervention was observed. Conclusion: the educational nursing intervention was effective in reducing phosphate and decreasing itching in hyperphosphatemic patients.

Bicarbonate-sensitive calcification and lifespan of klotho-deficient mice.

Klotho, a protein counteracting aging, is a powerful inhibitor of 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] formation and regulator of mineral metabolism. In klotho hypomorphic (kl/kl) mice, excessive 1,25(OH)2D3 formation leads to hypercalcemia, hyperphosphatemia and vascular calcification, severe growth deficits, accelerated aging and early death. Kl/kl mice further suffer from extracellular volume depletion and hypotension, leading to the stimulation of antidiuretic hormone and aldosterone release. A vitamin D-deficient diet, restriction of dietary phosphate, inhibition of mineralocorticoid receptors with spironolactone, and dietary NaCl all extend the lifespan of kl/kl mice. Kl/kl mice suffer from acidosis. The present study explored whether replacement of tap drinking water by 150 mM NaHCO3 affects the growth, tissue calcification, and lifespan of kl/kl mice. As a result, NaHCO3 administration to kl/kl mice did not reverse the growth deficit but substantially decreased tissue calcification and significantly increased the average lifespan from 78 to 127 days. NaHCO3 did not significantly affect plasma concentrations of 1,25(OH)2D3 and Ca(2+) but significantly decreased plasma phosphate concentration and plasma aldosterone concentration. The present study reveals a novel effect of bicarbonate, i.e., a favorable influence on vascular calcification and early death of klotho-deficient mice.

Additional benefit of dietitian involvement in dialysis staffs-led diet education on uncontrolled hyperphosphatemia in hemodialysis patients.

BACKGROUND: Sustained adherence to dietary phosphorus (P) restriction recommendations among hemodialysis patients is questionable. The aim of this study was to evaluate the effectiveness of additional diet education delivered by a dietitian on the control of hyperphosphatemia. METHODS: We conducted an 8-month prospective observational study in hemodialysis patients who had uncontrolled hyperphosphatemia. In the first half of the study (experimental) period, the dialysis nurses and physicians provided the routine dietetic education with the control group (n = 31), while the experimental group (n = 30) received the routine dietetic education plus an additional diet education delivered by dietitians. Both groups received the routine dietetic education in the rest of the study period to test whether the improvement of serum P level was sustained. The primary outcomes were changes in serum P level. RESULTS: At baseline, there was no significant difference in serum P levels between groups (P = 0.27). In the experimental period, monthly serum P levels decreased significantly in both groups (P < 0.001) and the magnitudes of reduction were 1.81 ± 1.46 and 0.94 ± 1.33 mg/dL in the experimental and control groups, respectively (P = 0.02), at the end. The experimental group maintained such improvement for one more month (P = 0.02), but faded out over time. CONCLUSION: Renal diet education guided either by dietitians plus dialysis staffs or dialysis staffs alone reduces serum P level and dietitian-guided diet education provides an additional benefit on controlling hyperphosphatemia in hemodialysis patients.

Prevalence of Phosphorus-Based Additives in the Australian Food Supply: A Challenge for Dietary Education?

OBJECTIVE: Phosphorus-based food additives may pose a significant risk in chronic kidney disease given the link between hyperphosphatemia and cardiovascular disease. The objective of the study was to determine the prevalence of phosphorus-based food additives in best-selling processed grocery products and to establish how they were reported on food labels. DESIGN: A data set of 3000 best-selling grocery items in Australia across 15 food and beverage categories was obtained for the 12 months ending December 2013 produced by the Nielsen Company's Homescan database. The nutrition labels of the products were reviewed in store for phosphorus additives. The type of additive, total number of additives, and method of reporting (written out in words or as an E number) were recorded. MAIN OUTCOME MEASURES: Presence of phosphorus-based food additives, number of phosphorus-based food additives per product, and the reporting method of additives on product ingredient lists. RESULTS: Phosphorus-based additives were identified in 44% of food and beverages reviewed. Additives were particularly common in the categories of small goods (96%), bakery goods (93%), frozen meals (75%), prepared foods (70%), and biscuits (65%). A total of 19 different phosphorus additives were identified across the reviewed products. From the items containing phosphorus additives, there was a median (minimum-maximum) of 2 (1-7) additives per product. Additives by E number (81%) was the most common method of reporting. CONCLUSION: Phosphorus-based food additives are common in the Australian food supply. This suggests that prioritizing phosphorus additive education may be an important strategy in the dietary management of hyperphosphatemia. Further research to establish a database of food items containing phosphorus-based additives is warranted.

Ferric citrate controls phosphorus and delivers iron in patients on dialysis.

Patients on dialysis require phosphorus binders to prevent hyperphosphatemia and are iron deficient. We studied ferric citrate as a phosphorus binder and iron source. In this sequential, randomized trial, 441 subjects on dialysis were randomized to ferric citrate or active control in a 52-week active control period followed by a 4-week placebo control period, in which subjects on ferric citrate who completed the active control period were rerandomized to ferric citrate or placebo. The primary analysis compared the mean change in phosphorus between ferric citrate and placebo during the placebo control period. A sequential gatekeeping strategy controlled study-wise type 1 error for serum ferritin, transferrin saturation, and intravenous iron and erythropoietin-stimulating agent usage as prespecified secondary outcomes in the active control period. Ferric citrate controlled phosphorus compared with placebo, with a mean treatment difference of -2.2±0.2 mg/dl (mean±SEM) (P<0.001). Active control period phosphorus was similar between ferric citrate and active control, with comparable safety profiles. Subjects on ferric citrate achieved higher mean iron parameters (ferritin=899±488 ng/ml [mean±SD]; transferrin saturation=39%±17%) versus subjects on active control (ferritin=628±367 ng/ml [mean±SD]; transferrin saturation=30%±12%; P<0.001 for both). Subjects on ferric citrate received less intravenous elemental iron (median=12.95 mg/wk ferric citrate; 26.88 mg/wk active control; P<0.001) and less erythropoietin-stimulating agent (median epoetin-equivalent units per week: 5306 units/wk ferric citrate; 6951 units/wk active control; P=0.04). Hemoglobin levels were statistically higher on ferric citrate. Thus, ferric citrate is an efficacious and safe phosphate binder that increases iron stores and reduces intravenous iron and erythropoietin-stimulating agent use while maintaining hemoglobin.

Icodextrin eliminates phosphate and ameliorates cardiac hypertrophy and valvular calcification in patients with end-stage renal disease and diabetes mellitus undergoing peritoneal dialysis.

Among end-stage renal disease (ESRD) patients, cardiovascular disease is a common comorbidity and one of most important factors affecting clinical prognosis. Calcium deposition has been reported to correlate with plasma phosphate. Icodextrin (Ico)-based peritoneal dialysis (PD) has many advantages over glucose (Glu)-based PD. We aimed to identify factors that suppress arteriosclerosis and valvular disease in patients with ESRD and diabetes mellitus (DM) undergoing Ico-based PD. In this retrospective study, we evaluated the effects of Ico-based PD (n = 20) on phosphate elimination and cardiovascular disease progression in patients with ESRD andDM, and we compared the results with those for Glu-based PD (n = 20). Left ventricular mass index (LVMI) and aortic valve calcification (AVC) score were significantly decreased and daily phosphate elimination was significantly increased in the Ico group compared with the Glu group. Furthermore, mean daily phosphate elimination was significantly and negatively correlated with the amelioration in LVMI and AVC score. Our study suggests that, compared with glucose, icodextrin has the ability to eliminate more phosphate from the body, indicating that phosphate elimination might potentially be a means of controlling cardiovascular disease in PD patients with DM.

Randomized clinical trial of the iron-based phosphate binder PA21 in hemodialysis patients.

BACKGROUND AND OBJECTIVES: A dose-finding study was undertaken to investigate the efficacy of PA21, a novel polynuclear iron(III)-oxyhydroxide phosphate binder. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In a randomized, active-controlled, multicenter, open-label study at 50 clinical sites in Europe and the United States, hemodialysis patients were randomized to PA21 at dosages of 1.25, 5.0, 7.5, 10.0, or 12.5 g/d or sevelamer-HCl 4.8 g/d for 6 weeks. The primary efficacy endpoint was the change in serum phosphorus concentration from baseline. RESULTS: There were 154 participants who were randomized and received the study drug. All groups except PA21 1.25 g/d showed a significant decrease in serum phosphorus. Mean decreases in serum phosphorus in PA21 10 g/d and 12.5 g/d were -2.00±1.71 mg/dl and -1.69±1.81 mg/dl, respectively. A similar decrease to sevelamer-HCl (-1.06±1.35 mg/dl) was seen with PA21 5.0 g/d (-1.08±2.12 mg/dl) and 7.5 g/d (-1.25±1.21 mg/d). Overall, 60.9% of participants randomized to PA21 and 57.7% randomized to sevelamer-HCl reported ≥1 adverse event. The most frequent adverse events were hypophosphatemia (18.0%) and discolored feces (11.7%) for the pooled PA21 dose groups, and diarrhea, hypophosphatemia, and hypotension (each 11.5%) for sevelamer-HCl. Discontinuation due to adverse events occurred at a similar rate in PA21-treated (21.1%) and sevelamer-HCl-treated (23.1%) participants. CONCLUSIONS: PA21 5-12.5 g/d significantly reduces serum phosphorus in hemodialysis patients. The 5 g/d and 7.5 g/d dosages showed similar efficacy to 4.8 g/d of sevelamer-HCl. The adverse events rate was similar for PA21 and sevelamer-HCl.