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Protein Supplementation in Dialysis Patients

This study has been terminated.
(lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367198
First Posted: August 22, 2006
Last Update Posted: July 12, 2011
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.
Information provided by:
Vanderbilt University
  Purpose
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.

Condition Intervention Phase
End Stage Renal Disease Dietary Supplement: Pro-Stat Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protein Supplementation in Dialysis Patients

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • net muscle protein balance [ Time Frame: 10 hours ]

Enrollment: 6
Study Start Date: August 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
30 ml per serving
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: 2
60 ml per serving
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
No Intervention: 3
chronic hemodialysis patients
No Intervention: 4
healthy subjects

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367198


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Alp Ikizler, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00367198     History of Changes
Other Study ID Numbers: 060587
First Submitted: August 18, 2006
First Posted: August 22, 2006
Last Update Posted: July 12, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases