#2538 HEALTHY PLANT-BASED DIET IN CHRONIC KIDNEY DISEASE THROUGH USE OF SODIUM ZIRCONIUM CYCLOSILICATE (HELPFUL TRIAL): LABORATORIAL FINDINGS

Abstract

Abstract Background and Aims Patients with chronic kidney disease (CKD) and hyperkalemia (HK) are counselled to follow a diet restricted in potassium (K) which limits the intake of fruits and vegetables. This is a cause of complaints for many patients. The use of the K lowering medication sodium zirconium cyclosilicate (SZC) has the potential to treat HK and allow a healthy plant-based diet (PBD). We designed a clinical trial to explore the safety and feasibility of prescribing a healthy PBD to CKD patients with HK with the concomitant use of SZC. Method The HELPFUL trial is an ongoing single-arm study with patients with CKD stage 4-5 not on dialysis and with plasma K between 5.1 to 6.5 mmol/L at inclusion. Patients are followed for 6 weeks. In the first 3 weeks, SZC is prescribed to normalize plasma K (pK) while ingesting a low protein diet with low K+ content. In the subsequent 3 weeks, a healthy PBD with a target K intake of 3700 mg/day is prescribed maintaining the use of SZC. A food basked with the PBD is delivered to the participants weekly. A weekly monitoring of pK and titration of SZC to keep normokalemia is performed. Other laboratorial measurements and food intake are assessed at baseline, week 3 and week 6. Food intake is evaluated using the 24-hour food record (24HFR). Data was analyzed by repeated measures-ANOVA or by Friedman test for related samples, as appropriate. The protocol is registered at www.clinicaltrials.gov (identifier NCT04207203). Results 22 patients were included (59±13 years; 13 men, 59%). Table 1 describes the main findings. During the study, eGFR did not change, serum urea decreased, and P-carbon dioxide increased significantly. Inflammatory markers, 24hour urinary sodium and K excretion did not change. Potassium intake from 24h-FR increased, as well as the intake of fruits, vegetables and nuts after the PBD. The mean pK normalized in week 3 and 6. After the start of PBD, 3 patients (13.6%) had pK between 5.1 and 5.3 mmol/L. Most patients needed SZC dose of 10g/day. No changes were observed in dose of RAAS. Conclusion The strategy of PBD food basket with concomitant use of SZC allowed an increase in dietary K intake with higher intake of fruits, vegetables and nuts. P-carbon dioxide, a surrogate of bicarbonate improved as well. The pK was kept withing normal values for most of the patients.