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NCT00367198 · ClinicalTrials.gov registry record · Phase 2
Protein Supplementation in Dialysis Patients
A Phase 2 study, sponsored by Vanderbilt University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00367198 is a Phase 2 study that was terminated before completion, run by Vanderbilt University. The registered enrollment target is 6 participants.
The verdict
NCT00367198, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
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.
Interventions
- DIETARY_SUPPLEMENT Pro-Stat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00367198
The ClinicalTrials.gov registry entry for NCT00367198 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pro-Stat is the first listed.
NCT00367198 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00367198 about?
NCT00367198 is a clinical study titled "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 deat...
What is the current status of trial NCT00367198?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2006-08. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00367198?
The interventions under investigation include: Pro-Stat (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00367198?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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