DaVita Assessment of Nutritional Supplement Effects (DANSE)

NCT00895401 | Completed Phase 4 DMC

• 1 other identifier: 2009-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Nutritional supplement; Malnutrition; Hemodialysis; Nepro with Carb Steady

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of Care for malnourished maintenance hemodialysis patients

Other: Standard of Care

Nepro with Carb Steady

EXPERIMENTAL

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

Interventions

Nepro with Carb Steady DIETARY_SUPPLEMENT

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.

Also known as: Oral Nutritional Supplement

Nepro with Carb Steady

Standard of Care OTHER

Standard of Care for malnourished maintenance hemodialysis patients

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Davita Clinical Research: lead
• Abbott Nutrition: collaborator

Study Sites (1)

DaVita

Irvine, California, 92618, United States

Location

Related Publications (1)

• 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.

  PMID: 32390133 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements; Standard of Care

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Debbie Benner, MA

  DaVita, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: April 1, 2009
• Primary Completion: January 1, 2011
• Last Updated: February 8, 2011

Record last verified: 2011-02

Locations

US (1)