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NCT00895401 · ClinicalTrials.gov registry record · Phase 4
DaVita Assessment of Nutritional Supplement Effects (DANSE)
A Phase 4 study of Malnutrition, sponsored by Davita Clinical Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT00895401 is a Phase 4 study of Malnutrition that has completed, run by Davita Clinical Research. The registered enrollment target is 160 participants, below the 379-participant average among 17 other Malnutrition trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00895401, a Phase 4 study of Malnutrition, has completed, sponsored by Davita Clinical Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to receive the standard of care counseling for malnutrition. The primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate an improvement in albumin levels with oral nutritional supplement provided in-center thrice weekly in addition to standard of care as compared to malnourished maintenance hemodialysis patients provided standard of care alone.
Conditions Studied
Interventions
- OTHER Standard of Care
- DIETARY_SUPPLEMENT Nepro with Carb Steady
Study Locations (1)
California
- DaVita - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2009-04 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00895401
The ClinicalTrials.gov registry entry for NCT00895401 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 17 other Malnutrition trials with a reported enrollment target (58% lower). The listed sponsor is Davita Clinical Research, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malnutrition appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT00895401 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00895401 about?
NCT00895401 is a clinical study titled "DaVita Assessment of Nutritional Supplement Effects (DANSE)". This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to...
What is the current status of trial NCT00895401?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2009-04.
What conditions does trial NCT00895401 study?
This clinical trial studies the following conditions: Malnutrition.
What interventions are being tested in trial NCT00895401?
The interventions under investigation include: Standard of Care (OTHER), Nepro with Carb Steady (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00895401?
This trial is sponsored by Davita Clinical Research, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00895401 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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