Complementary Intradialytic Nutritional Supplementation in Dialysis Patients
Stopped early · Phase 2 · Has a placebo group
Conditions studied: End Stage Renal Disease
In brief
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.
Key facts
- Study ID
- NCT00179205
- Run by
- Vanderbilt University
- People needed
- 27
- Starts
- 2005-05-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2008-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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