Clinical trial NCT00895401: DaVita Assessment of Nutritional Supplement Effects (DANSE)
Official title: DaVita Assessment of Nutritional Supplement Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Keywords: Nutritional supplement
Malnutrition
Hemodialysis
Nepro with Carb Steady
Lead sponsor: Davita Clinical Research
Sponsor class: INDUSTRY
Collaborators: name: Abbott Nutrition
First posted: 2009-05-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Monthly for the 6 month study period
Secondary outcomes:
measure: Malnutrition Inflammation Score (MIS)
timeFrame: Month 0 and Month 6
measure: Body Mass Index (BMI)
timeFrame: Monthly for the 6 month study period
measure: Estimated Dry Weight (EDW)
timeFrame: Monthy for the 6 monthly study period
measure: Prealbumin level
timeFrame: Months 0,2,4,&6
measure: C-Reactive protein level
timeFrame: Month 0,3 &6
Other outcomes:
Locations:
city: Irvine
country: United States
facility: DaVita
state: California
Study officials:
affiliation: DaVita Dialysis
name: Debbie Benner, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.