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NCT01814527 · ClinicalTrials.gov registry record · NA
High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions
A NA study of Brain Concussion and Cerebral Concussion, sponsored by East Carolina University.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT01814527: Completed NA study of Brain Concussion and Cerebral Concussion, sponsored by East Carolina University.
NCT01814527 is a NA study of Brain Concussion and Cerebral Concussion that has completed, run by East Carolina University. The registered enrollment target is 62 participants, below the 294-participant average among 17 other Brain Concussion trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01814527, a NA study of Brain Concussion and Cerebral Concussion, has completed, sponsored by East Carolina University.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
Concussions are defined as a complex pathophysiological process affecting the brain, induced by traumatic biomechanical forces. Currently the standard of care in the treatment for concussions is cognitive and physical rest until symptoms resolve with a graduated return to activity. High dose omega-3 fatty acids have shown to have anti-inflammatory, anti-oxidant, and membrane stabilizing properties. They have also been used in treatment of severe traumatic brain injury. The purpose of this study is to determine if early high dose omega-3 fatty acid supplementation in Division I National Collegiate Athletic Association (NCAA) athletes that have sustained a concussion will decrease the number of days out of competitive sports with a quicker symptom resolution, return to baseline neurocognitive functioning and postural stability using a randomized double blind placebo controlled study design. Once an athlete is identified as having sustained a concussion by the East Carolina University Sports Medicine staff and qualifies for the study, he/she will randomly be assigned to either high dose omega-3 fatty acid or placebo. Both groups will undergo standard and usual care for concussed athletes at East Carolina University. The number of days it takes the athlete to return to competitive athletics will be recorded, along with time to symptom resolution, normalization of their computerized neurocognitive testing (ImPact) and computerized postural stability testing (Biodex BioSway).
Primary Outcome
Primary outcome will be the total number of days from onset of concussion it takes for the athlete to return to unrestricted full participation in their respective sport.
Conditions Studied
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT Docosahexaenoic acid
Study Locations (1)
North Carolina
- East Carolina University - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-07 |
| Phase | NA |
What the finished NCT01814527 record still lists
NCT01814527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 294-participant average among 17 other Brain Concussion trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Brain Concussion appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01814527 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01814527 about?
NCT01814527 is a clinical study titled "High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions". Concussions are defined as a complex pathophysiological process affecting the brain, induced by traumatic biomechanical forces. Currently the standard of care in the treatment for concussions is cognitive and physical rest until symptoms resolve with a graduated return to activity. High dose omega-3...
What is the current status of trial NCT01814527?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2013-07. Estimated completion is 2017-07.
What conditions does trial NCT01814527 study?
This clinical trial studies the following conditions: Brain Concussion, Cerebral Concussion, Mild Concussion.
What interventions are being tested in trial NCT01814527?
The interventions under investigation include: Placebo (DRUG), Docosahexaenoic acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01814527?
This trial is sponsored by East Carolina University, which has 58 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01814527 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01814527's enrollment target sits among peer trials
62 10th of 17 higher than 8 of 17 other Brain Concussion trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Concussion 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.
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