Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Vanderbilt University1 site in 1 country27 target enrollmentMay 2005

ConditionsEnd Stage Renal Disease

InterventionsNepro nutritional supplement placebo

DrugsNepro nutritional supplement placebo

Overview

Phase: Phase 2
Intervention: Nepro nutritional supplement
Conditions: End Stage Renal Disease
Sponsor: Vanderbilt University
Enrollment: 27
Locations: 1
Primary Endpoint: increase in serum albumin
Status: Terminated
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, the investigators hypothesize that long-term administration of adequate intradialytic oral nutritional supplementation will increase visceral protein concentrations and somatic protein stores in malnourished chronic hemodialysis patients.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

December 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Vanderbilt University

Eligibility Criteria

Inclusion Criteria

•On hemodialysis for more than 6 months
•Optimally dialyzed with a biocompatible membrane (URR \> 70% and/or delivered Kt/V \> 1.2)
•Suboptimal nutritional status identified by:
•Serum albumin less than or equal to 3.90 g/dl and one of the three following criteria:
•Protein catabolic rate less than 0.95 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months
•Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight over the past 6 months and/or patients who are less than 90% of standard body weight
•Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements over the consecutive two months prior to inclusion:
•Serum transferrin concentration less than 225 mg/dl
•Serum prealbumin concentration less than 32 mg/dl