Protein Supplementation in Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00367198
Recruitment Status : Terminated (lack of enrollment)
First Posted : August 22, 2006
Last Update Posted : July 12, 2011
Information provided by:
Vanderbilt University

August 18, 2006
August 22, 2006
July 12, 2011
August 2006
November 2007   (Final data collection date for primary outcome measure)
net muscle protein balance [ Time Frame: 10 hours ]
net muscle protein balance
Complete list of historical versions of study NCT00367198 on Archive Site
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Protein Supplementation in Dialysis Patients
Protein Supplementation in Dialysis Patients
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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Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
End Stage Renal Disease
Dietary Supplement: Pro-Stat
two separate oral ingestions of nutrition supplement (either 30 ml per serving or at 60 ml per serving) during the hemodialysis session
  • Active Comparator: 1
    30 ml per serving
    Intervention: Dietary Supplement: Pro-Stat
  • Active Comparator: 2
    60 ml per serving
    Intervention: Dietary Supplement: Pro-Stat
  • No Intervention: 3
    chronic hemodialysis patients
  • No Intervention: 4
    healthy subjects
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2007
November 2007   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program.
  • Adequately dialyzed (Kt/V > 1.2).
  • Age 18-75

Exclusion criteria:

  • Pregnant women.
  • Severe unstable underlying disease besides commonly associated with end stage renal disease. Cardiac patients that are stable will be included.
  • Patients hospitalized within the last month prior to the study.
  • Patients with malfunctioning arterial-venous access [recirculation and/or blood flow < 500 ml/min for an arterial-venous graft (AVG) or <400 ml/min for an arterial-venous fistula (AVF)] Patients receiving steroids and/or other immunosuppressive agents.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Alp Ikizler, MD, Vanderbilt University Medical Center
Vanderbilt University
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Principal Investigator: Alp Ikizler, MD Vanderbilt University Medical Center
Vanderbilt University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP