This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to receive the standard of care counseling for malnutrition. The primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate an improvement in albumin levels with oral nutritional supplement provided in-center thrice weekly in addition to standard of care as compared to malnourished maintenance hemodialysis patients provided standard of care alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Nepro with Carb Steady is a commercially available renal specific oral nutritional supplement designed to meet the nutrient needs of dialysis patients. The supplement is 8 oz and provides 425 kcal and 19 grams of protein.
Standard of Care for malnourished maintenance hemodialysis patients
DaVita
Irvine, California, United States
The primary outcome measure of this study is albumin level, both mean albumin level and percentage of patients achieving an albumin level of >3.8 and > 4.0
Time frame: Monthly for the 6 month study period
Malnutrition Inflammation Score (MIS)
Time frame: Month 0 and Month 6
Body Mass Index (BMI)
Time frame: Monthly for the 6 month study period
Estimated Dry Weight (EDW)
Time frame: Monthy for the 6 monthly study period
Prealbumin level
Time frame: Months 0,2,4,&6
C-Reactive protein level
Time frame: Month 0,3 &6
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