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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: Clinical Trial Phase 2 study, sponsored by Vanderbilt University.
NCT00367198 is a Phase 2 study that was terminated before completion, run by Vanderbilt University. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00367198 stopped before completion
NCT00367198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Pro-Stat is the first listed.
NCT00367198 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00367198's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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