DaVita
Irvine, California, 92618, United States
NCT Number: NCT00895401
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Irvine, California, 92618, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 for malnourished maintenance hemodialysis patients
Time frame: Monthly for the 6 month study period
Time frame: Month 0 and Month 6
Time frame: Monthly for the 6 month study period
Time frame: Monthy for the 6 monthly study period
Time frame: Months 0,2,4,&6
Time frame: Month 0,3 &6
Davita Clinical Research
Industry
DaVita Assessment of Nutritional Supplement Effects
Acronym: DANSE
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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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