End Stage Renal Disease
Conditions
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.
Interventions
oral nutritional supplement (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 480 calories: 71 calories from protein, 206 calories from carbohydrates and 206 calories from fat.
DRUGplacebo
oral placebo (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 60 calories: 0 calories from protein, 60 calories from carbohydrates, and 0 calories from fat.
Sponsors
Ross Laboratories
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| increase in serum albumin | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| increase in lean body mass | 6 months |
Countries
United States
Outcome results
None listed