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NCT02837861 · ClinicalTrials.gov registry record · Early Phase 1
Early and Adequate Protein Feeding Post-Traumatic Injury
A Early Phase 1 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 45
- Enrollment target
NCT02837861 is a Early Phase 1 study that has completed, run by Boston Medical Center. The registered enrollment target is 45 participants.
The verdict
NCT02837861, a Early Phase 1 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
A randomized, parallel-group, pilot study comparing the effect of the early addition of intravenous protein to enteral feeding as tolerated versus enteral feedings as tolerated alone immediately post traumatic injury. Primary: To determine that early and adequate nutritional support will improve protein economy in the first week post -injury as measured by nitrogen balance. We hypothesize that an improvement in nitrogen balance with early maximized protein intake will support the production of acute phase proteins, major antioxidants and the inflammatory response. Secondary: Through the use of mass spectrometry (MS) and nuclear magnetic resonance (NMR) technologies we will determine that our plan for early and adequate nutritional support with adequate protein from day one post injury will alter the metabolomics profile when compared to routine nutritional support. Tertiary: For Specific Aim 3 we will measure several pro- and anti-inflammatory cytokines and soluble proteins.
Interventions
- DRUG Routine Nutritional Support plus supplemental IV amino acids
- OTHER Routine Nutritional Support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-03-07 |
| Est. Completion | 2019-10-18 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02837861
The ClinicalTrials.gov registry entry for NCT02837861 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Routine Nutritional Support plus supplemental IV amino acids is the first listed.
NCT02837861 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02837861 about?
NCT02837861 is a clinical study titled "Early and Adequate Protein Feeding Post-Traumatic Injury". A randomized, parallel-group, pilot study comparing the effect of the early addition of intravenous protein to enteral feeding as tolerated versus enteral feedings as tolerated alone immediately post traumatic injury. Primary: To determine that early and adequate nutritional support will improve pr...
What is the current status of trial NCT02837861?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 45 participants. The study started on 2017-03-07. Estimated completion is 2019-10-18.
What interventions are being tested in trial NCT02837861?
The interventions under investigation include: Routine Nutritional Support plus supplemental IV amino acids (DRUG), Routine Nutritional Support (OTHER).
Who is sponsoring clinical trial NCT02837861?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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