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DaVita Assessment of Nutritional Supplement Effects (DANSE) (DANSE)

Primary Purpose

Malnutrition

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nepro with Carb Steady
Standard of Care
Sponsored by
Davita Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Nutritional supplement, Malnutrition, Hemodialysis, Nepro with Carb Steady

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DaVita

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Nepro with Carb Steady

Arm Description

Standard of Care for malnourished maintenance hemodialysis patients

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Malnutrition Inflammation Score (MIS)
Body Mass Index (BMI)
Estimated Dry Weight (EDW)
Prealbumin level
C-Reactive protein level

Full Information

First Posted
May 7, 2009
Last Updated
February 5, 2011
Sponsor
Davita Clinical Research
Collaborators
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT00895401
Brief Title
DaVita Assessment of Nutritional Supplement Effects (DANSE)
Acronym
DANSE
Official Title
DaVita Assessment of Nutritional Supplement Effects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Davita Clinical Research
Collaborators
Abbott Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Nutritional supplement, Malnutrition, Hemodialysis, Nepro with Carb Steady

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of Care for malnourished maintenance hemodialysis patients
Arm Title
Nepro with Carb Steady
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Nepro with Carb Steady
Other Intervention Name(s)
Oral Nutritional Supplement
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care for malnourished maintenance hemodialysis patients
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Malnutrition Inflammation Score (MIS)
Time Frame
Month 0 and Month 6
Title
Body Mass Index (BMI)
Time Frame
Monthly for the 6 month study period
Title
Estimated Dry Weight (EDW)
Time Frame
Monthy for the 6 monthly study period
Title
Prealbumin level
Time Frame
Months 0,2,4,&6
Title
C-Reactive protein level
Time Frame
Month 0,3 &6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debbie Benner, MA
Organizational Affiliation
DaVita Dialysis
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32390133
Citation
Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
Results Reference
derived

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DaVita Assessment of Nutritional Supplement Effects (DANSE)

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