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Protein Supplementation in Dialysis Patients

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clinicaltrials.gov/study/NCT00367198
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT003671980
Trial Recruitment Size
60
Trial Sponsor
Vanderbilt University
Vanderbilt University
0
Clinical Trial Start Date
2006
0
Primary Completion Date
2007
0
Study Completion Date
2007
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Dietary Supplement0
Interventional Trial Phase
Phase 20
Participating Facility
‌
Vanderbilt University Medical Center
0
Official Name
Protein Supplementation in Dialysis Patients0
Last Updated
July 12, 2011
0
Allocation Type
Randomized0
Intervention Model
Crossover Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Pro-Stat0
Study summary

The mortality rate in chronic hemodialysis (CHD) patients remains excessively high and approaches 21% per year. Among the many factors that adversely affects patient outcome is uremic malnutrition, a unique form of deranged nutritional status. It is associated with increased hospitalization and death risk in CHD patients. Several measures have been identified to prevent uremic malnutrition in CHD patients, including efforts to optimize dialysis regimen and dietary protein and energy intake. A large number of CHD patients suffer from uremic malnutrition in spite of these aggressive measures. The inevitable protein catabolic effects of the hemodialysis procedure are important factors leading to increased prevalence of uremic malnutrition. Preliminary data suggest that oral nutritional supplementation administered during the hemodialysis procedure counteracts these protein catabolic effects and leads to net protein anabolism in the acute setting. In this proposal, we hypothesize that Pro-Stat, a high nitrogen, enzyme-hydrolyzed, tryptophan-fortified, collagen protein supplement will reverse the net protein catabolism observed during hemodialysis procedure.

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