Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: Nepro nutritional supplement
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Nepro nutritional supplement<br>* 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.<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in serum albumin |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in lean body mass |  | 6 months |