Trial Outcomes & Findings for High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions (NCT NCT01814527)
NCT ID: NCT01814527
Last Updated: 2024-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
30 days
Results posted on
2024-04-24
Participant Flow
62 NCAA Division I Student Athletes were recruited during the 2013-2017 academic years.
Participant milestones
| Measure |
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.
Docosahexaenoic acid: 5 capsules containing 440mg of Docosahexaenoic acid (DHA)for total daily dosing of 2200mg of DHA daily
|
Placebo
The placebo group will be given an equal amount of capsules.
Placebo: 5 capsules that are identical to the treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
33
|
|
Overall Study
COMPLETED
|
23
|
32
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
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.
Docosahexaenoic acid: 5 capsules containing 440mg of Docosahexaenoic acid (DHA)for total daily dosing of 2200mg of DHA daily
|
Placebo
The placebo group will be given an equal amount of capsules.
Placebo: 5 capsules that are identical to the treatment.
|
|---|---|---|
|
Overall Study
RTP greater than 30 days
|
6
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Docosahexaenoic Acid
n=23 Participants
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.
Docosahexaenoic acid: 5 capsules containing 440mg of Docosahexaenoic acid (DHA)for total daily dosing of 2200mg of DHA daily
|
Placebo
n=32 Participants
The placebo group will be given an equal amount of capsules.
Placebo: 5 capsules that are identical to the treatment.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=55 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=23 Participants
|
32 Participants
n=32 Participants
|
55 Participants
n=55 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=23 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=55 Participants
|
|
Age, Continuous
|
19.7 years
STANDARD_DEVIATION 1.4 • n=23 Participants
|
19.9 years
STANDARD_DEVIATION 1.4 • n=32 Participants
|
19.8 years
STANDARD_DEVIATION 1.4 • n=55 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=23 Participants
|
13 Participants
n=32 Participants
|
22 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=23 Participants
|
19 Participants
n=32 Participants
|
33 Participants
n=55 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
23 Participants
n=23 Participants
|
32 Participants
n=32 Participants
|
55 Participants
n=55 Participants
|
|
BMI
|
27.7 kg/m^2
STANDARD_DEVIATION 6.1 • n=23 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 6.1 • n=32 Participants
|
28 kg/m^2
STANDARD_DEVIATION 6.1 • n=55 Participants
|
PRIMARY outcome
Timeframe: 30 daysPrimary 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.
Outcome measures
| Measure |
Docosahexaenoic Acid
n=23 Participants
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.
Docosahexaenoic acid: 5 capsules containing 440mg of Docosahexaenoic acid (DHA)for total daily dosing of 2200mg of DHA daily
|
Placebo
n=32 Participants
The placebo group will be given an equal amount of capsules.
Placebo: 5 capsules that are identical to the treatment.
|
|---|---|---|
|
Number of Days to Return to Full Unrestricted Athletic Participation
|
11.0 Days
Interval 9.1 to 13.0
|
11.9 Days
Interval 10.0 to 13.8
|
Adverse Events
Docosahexaenoic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place