MedTrace Logo

DaVita Assessment of Nutritional Supplement Effects (DANSE)

NCT00895401 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2011-02-08

No results posted yet for this study

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.

Conditions

  • Malnutrition

Interventions

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

Standard of Care

Standard of Care for malnourished maintenance hemodialysis patients

Sponsors & Collaborators

  • Abbott Nutrition

    collaborator INDUSTRY

  • Davita Clinical Research

    lead INDUSTRY

Principal Investigators

  • Debbie Benner, MA · DaVita, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00895401 on ClinicalTrials.gov