NCT00895401

DaVita Assessment of Nutritional Supplement Effects (DANSE)

DaVita Assessment of Nutritional Supplement Effects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Davita Clinical Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-01-01
• First posted: 2009-05-08
• Last updated: 2011-02-08

Locations

1 site across 1 country: United States