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OpenTrials
Completed

NCT Number: NCT00895401

DaVita Assessment of Nutritional Supplement Effects (DANSE)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DaVita

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Oral Nutritional Supplement

Standard of care

Other

Standard of Care for malnourished maintenance hemodialysis patients

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

    Time frame: Monthly for the 6 month study period

Secondary outcomes

  1. Malnutrition Inflammation Score (MIS)

    Time frame: Month 0 and Month 6

  2. Body Mass Index (BMI)

    Time frame: Monthly for the 6 month study period

  3. Estimated Dry Weight (EDW)

    Time frame: Monthy for the 6 monthly study period

  4. Prealbumin level

    Time frame: Months 0,2,4,&6

  5. C-Reactive protein level

    Time frame: Month 0,3 &6

Sponsors and collaborators

Lead sponsor

Davita Clinical Research

Industry

Collaborators

  • Abbott Nutrition

Registry information

Official study title

DaVita Assessment of Nutritional Supplement Effects

Acronym: DANSE

Important dates

Study start
2009
Primary completion
2011
First posted
May 8, 2009
Registry last updated
Feb 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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