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Protein Supplementation in Dialysis Patients

This study has been terminated.
(lack of enrollment)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00367198
First received: August 18, 2006
Last updated: July 11, 2011
Last verified: July 2011
History of Changes

August 18, 2006
July 11, 2011
August 2006
November 2007   (final data collection date for primary outcome measure)
net muscle protein balance [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
net muscle protein balance
Complete list of historical versions of study NCT00367198 on ClinicalTrials.gov 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00367198
060587
No
Alp Ikizler, MD, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Alp Ikizler, MD Vanderbilt University
Vanderbilt University
July 2011

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