DaVita Assessment of Nutritional Supplement Effects (DANSE)

Malnutrition Clinical Trial

— DANSE  

Official title:

DaVita Assessment of Nutritional Supplement Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895401
• Other study ID #: 2009-001
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2009
• Last updated: February 5, 2011
• Start date: April 2009

Study information

• Verified date: February 2011
• Source: Davita Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
United States	DaVita	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
Davita Clinical Research	Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Malnutrition Inflammation Score (MIS)		Month 0 and Month 6	No
Secondary	Body Mass Index (BMI)		Monthly for the 6 month study period	No
Secondary	Estimated Dry Weight (EDW)		Monthy for the 6 monthly study period	No
Secondary	Prealbumin level		Months 0,2,4,&6	No
Secondary	C-Reactive protein level		Month 0,3 &6	No