High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01814527|
Recruitment Status : Completed
First Posted : March 20, 2013
Last Update Posted : September 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mild Concussion Brain Concussion Cerebral Concussion||Dietary Supplement: Docosahexaenoic acid Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions|
|Actual Study Start Date :||July 2013|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Active Comparator: Docosahexaenoic acid
The experimental group will be given a standardized dose of omega-3 fatty acid containing 2200mg of DHA for 30 days after onset of concussion or longer for those with continued symptomatology. Brain Armor an over the counter DHA supplements that is independently tested and certified by the National Science Foundation Athletic Banned Substance Certified for Sport Program. The Docosahexaenoic acid supplement has 440mg of DHA per capsule and each subject will be given 5 capsules of Brain Armor once daily for a DHA dose of 2200mg/day.
Dietary Supplement: Docosahexaenoic acid
5 capsules containing 440mg of Docosahexaenoic acid (DHA)for total daily dosing of 2200mg of DHA daily
Other Name: Omega-3 Fatty Acids
Placebo Comparator: Placebo
The placebo group will be given an equal amount of capsules.
5 capsules that are identical to the treatment.
- Number of days to return to full unrestricted athletic participation [ Time Frame: 30 days ]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.
- Number of days for balance and cognition to return to baseline [ Time Frame: 30 days ]One of the secondary outcome will be the rate of change in the ImPact composite raw scores and percentiles from time of injury to the time of final sport clearance. Each composite raw score with percentiles including verbal memory, visual memory, visual motor speed, reaction time, impulse control and total composite score will be analyzed. Another outcome will be the rate change in the Biodex BioSway from time of injury to time of final sport clearance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814527
|United States, North Carolina|
|East Carolina University|
|Greenville, North Carolina, United States, 27834|
|Principal Investigator:||David P Bica, DO||East Carolina University|
|Principal Investigator:||Joseph Armen, DO||East Carolina University|