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Protein Supplementation in Dialysis Patients

Primary Purpose

End Stage Renal Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pro-Stat
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

No Intervention

No Intervention

Arm Label

1

2

3

4

Arm Description

30 ml per serving

60 ml per serving

chronic hemodialysis patients

healthy subjects

Outcomes

Primary Outcome Measures

net muscle protein balance

Secondary Outcome Measures

Full Information

First Posted
August 18, 2006
Last Updated
July 11, 2011
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00367198
Brief Title
Protein Supplementation in Dialysis Patients
Official Title
Protein Supplementation in Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
30 ml per serving
Arm Title
2
Arm Type
Active Comparator
Arm Description
60 ml per serving
Arm Title
3
Arm Type
No Intervention
Arm Description
chronic hemodialysis patients
Arm Title
4
Arm Type
No Intervention
Arm Description
healthy subjects
Intervention Type
Dietary Supplement
Intervention Name(s)
Pro-Stat
Intervention Description
two separate oral ingestions of nutrition supplement (either 30 ml per serving or at 60 ml per serving) during the hemodialysis session
Primary Outcome Measure Information:
Title
net muscle protein balance
Time Frame
10 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32390133
Citation
Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
Results Reference
derived

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Protein Supplementation in Dialysis Patients

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