DaVita Assessment of Nutritional Supplement Effects (DANSE)

Study Overview
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Brief Summary
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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.

Official Title
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DaVita Assessment of Nutritional Supplement Effects

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Nepro with Carb Steady
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years of age Patient has been on hemodialysis >6 months at the time of study entry Patient dialyzes three times a week Patient agrees to try ONS for the 6 month study period. Patient has demonstrated an albumin <3.5 g/dL on last available lab drawn in dialysis facility Patient is adequately dialyzed with a Kt/V > 1.4 at the most recent lab draw Patient is capable of reading and comprehending Informed Consent Form and provides written informed consent Exclusion Criteria: Peritoneal dialysis Dysphagia Aspiration risk Difficulty swallowing History of symptomatic intolerance to food or liquid consumption during dialysis treatments Terminal illnesses with life expectancy <6 months, e.g. stage IV cancer or full blown AIDS Concurrent appetite stimulants Use of IDPN in last 3 months Inability to follow and to comply with the instructions and guidelines Severe liver disease defined as most recent SGOT > 78 Active malignancy (other than skin) Major surgery within previous 6 months or anticipated during the 90-day study period Females who are pregnant or are breast-feeding Considered clinically unstable by the treating nephrologists Noncompliance with dialysis treatments ( Missed > 2 treatments in prior month due to noncompliance) Extended or frequent hospitalizations defined as hospitalization of longer than 15 days with discharge within the last 30 days or greater than 3 admissions within the last 30 days Regular supplement use defined as consumption of > 7 servings of a commercially available kcal/ protein supplement in the prior month Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Standard of Care for malnourished maintenance hemodialysis patients | Other: Standard of Care<br>* Standard of Care for malnourished maintenance hemodialysis patients<br>|
| Experimental: Nepro with Carb Steady<br>Nepro with Carb Steady is a commercially available nutritional supplement designed to meet the nutritional needs of malnourished hemodialysis patients. The serving size is 8 oz which provides 425 kcal and 19 g protein | Dietary Supplement: Nepro with Carb Steady<br>* 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.<br>* Other names: Oral Nutritional Supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Monthly for the 6 month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malnutrition Inflammation Score (MIS) |  | Month 0 and Month 6 | 
| Body Mass Index (BMI) |  | Monthly for the 6 month study period | 
| Estimated Dry Weight (EDW) |  | Monthy for the 6 monthly study period | 
| Prealbumin level |  | Months 0,2,4,&6 | 
| C-Reactive protein level |  | Month 0,3 &6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional supplement, Malnutrition, Hemodialysis, Nepro with Carb Steady