Status:
TERMINATED
Complementary Intradialytic Nutritional Supplementation in Dialysis Patients
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Ross Laboratories
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Active auto-immune, inflammatory or infectious disease
- Documented malignancy within the last 12 months
- Patients on unusual dietary restrictions
- Life-expectancy less than 6 months
- Inability to tolerate nutritional supplements
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00179205
Start Date
May 1 2005
End Date
December 1 2007
Last Update
August 6 2008
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232