DaVita Assessment of Nutritional Supplement Effects (DANSE)

This study has been completed.
Sponsor:
Collaborator:
Abbott Nutrition
Information provided by:
Davita Clinical Research
ClinicalTrials.gov Identifier:
NCT00895401
First received: May 7, 2009
Last updated: February 5, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Malnutrition
Dietary Supplement: Nepro with Carb Steady
Other: Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DaVita Assessment of Nutritional Supplement Effects

Resource links provided by NLM:


Further study details as provided by Davita Clinical Research:

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 [ Time Frame: Monthly for the 6 month study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Malnutrition Inflammation Score (MIS) [ Time Frame: Month 0 and Month 6 ] [ Designated as safety issue: No ]
  • Body Mass Index (BMI) [ Time Frame: Monthly for the 6 month study period ] [ Designated as safety issue: No ]
  • Estimated Dry Weight (EDW) [ Time Frame: Monthy for the 6 monthly study period ] [ Designated as safety issue: No ]
  • Prealbumin level [ Time Frame: Months 0,2,4,&6 ] [ Designated as safety issue: No ]
  • C-Reactive protein level [ Time Frame: Month 0,3 &6 ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: April 2009
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care
Standard of Care for malnourished maintenance hemodialysis patients
Other: Standard of Care
Standard of Care for malnourished maintenance hemodialysis patients
Experimental: Nepro with Carb Steady
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
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.
Other Name: Oral Nutritional Supplement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895401

Locations
United States, California
DaVita
Irvine, California, United States, 92618
Sponsors and Collaborators
Davita Clinical Research
Abbott Nutrition
Investigators
Principal Investigator: Debbie Benner, MA DaVita Dialysis
  More Information

No publications provided

Responsible Party: Debbie Benner, MA, RD, CSE, DaVita, Inc
ClinicalTrials.gov Identifier: NCT00895401     History of Changes
Other Study ID Numbers: 2009-001
Study First Received: May 7, 2009
Last Updated: February 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Davita Clinical Research:
Nutritional supplement
Malnutrition
Hemodialysis
Nepro with Carb Steady

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 21, 2014