Status:
COMPLETED
DaVita Assessment of Nutritional Supplement Effects (DANSE)
Lead Sponsor:
Davita Clinical Research
Collaborating Sponsors:
Abbott Nutrition
Conditions:
Malnutrition
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 randomiz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00895401
Start Date
April 1 2009
Last Update
February 8 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
DaVita
Irvine, California, United States, 92618