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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: Completed Early Phase 1 study, sponsored by Boston Medical Center.
NCT02837861 is a Early Phase 1 study that has completed, run by Boston Medical Center. The registered enrollment target is 45 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We will use the urine specimen collections to measure nitrogen balance and catabolic index, both of which assess the level of physiologic stress. A catabolic Index less than zero represents no significant stress, an index greater than or equal to zero and less than or equal to 5 represents moderate stress, and an index greater than 5 represents severe stress. Twenty-four hour urine collections will be done for measurement of urine urea nitrogen to estimate nitrogen balance on day 1 and day 5 or
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 |
What the finished NCT02837861 record still lists
NCT02837861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02837861's enrollment target sits among peer trials
45 575th of 2000 higher than 1,412 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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