DaVita Assessment of Nutritional Supplement Effects (DANSE)

DaVita

Status and phase: Completed; Phase 4

Conditions: Malnutrition

Treatments: Dietary Supplement: Nepro with Carb Steady; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00895401

2009-001

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Standard of Care for malnourished maintenance hemodialysis patients

Treatment:

Other: Standard of Care

Nepro with Carb Steady

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nepro with Carb Steady