Dietary Protein Requirements in Hemodialysis Patients

End-Stage Renal Disease Clinical Trial

Official title: Dietary Protein Intake and Its Effect on Nitrogen Balance in Maintenance Hemodialysis (MHD) Patients

Status Completed

Clinical Trial Summary

The primary purpose of this study is to assess dietary protein requirements in clinically stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.

Clinical Trial Description

A high proportion of maintenance hemodialysis (MHD) patients have protein-energy malnutrition (PEM) which is a powerful predictor of high morbidity and mortality. Although inflammation may contribute to PEM, low dietary protein intake (DPI) is often a contributing factor. The usual DPI of MHD patients in about 1.0 g protein/kg/day, whereas expert groups recommend = 1.20 g protein/kg/day. However, these recommendations are based upon few studies, often of insufficient duration, that were usually carried out with obsolete types of dialysis therapy.

We will examine the response to different levels of dietary protein intake (0.6-1.3 g protein/kg/day) under classical balance techniques with carefully controlled dietary intakes, living, conditions, and collection of nitrogen outputs and carefully measured nitrogen intakes and outputs. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Renal Failure
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

• NCT number: NCT02194114
• Study type: Interventional
• Source: Los Angeles Biomedical Research Institute
• Status: Completed
• Phase: N/A
• Start date: January 2004
• Completion date: January 2008