Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Phase 2

Terminated

• Conditions: End Stage Renal Disease
• Interventions: Drug: Nepro nutritional supplement; Drug: placebo

• Registration Number: NCT00179205
• Lead Sponsor: Vanderbilt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2006-11
• Study Completion: 2007-12
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-05
• Last Update Posted: 2008-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. On hemodialysis for more than 6 months

2. Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V > 1.2)

3. 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

Exclusion Criteria

1. Active auto-immune, inflammatory or infectious disease
2. Documented malignancy within the last 12 months
3. Patients on unusual dietary restrictions
4. Life-expectancy less than 6 months
5. Inability to tolerate nutritional supplements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Nepro nutritional supplement	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
increase in serum albumin	6 months

Secondary Outcome Measures

Name	Time	Method
increase in lean body mass	6 months

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States