Trial Outcomes & Findings for OPTIMA-TBI Pilot Study (NCT NCT03345550)
NCT ID: NCT03345550
Last Updated: 2023-05-23
Results Overview
Neuronal injury measured by Neurofilament Light Chain (NFL). Samples will be analyzed using a digital immunoassay based on a single molecule counting technology.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline,3 months
Results posted on
2023-05-23
Participant Flow
Participant milestones
| Measure |
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
|
Placebo Arm
Participants randomized to this study arm received placebo drug for 3 months.
Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
First Received Drug
|
22
|
22
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
|
Placebo Arm
Participants randomized to this study arm received placebo drug for 3 months.
Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
Baseline Characteristics
OPTIMA-TBI Pilot Study
Baseline characteristics by cohort
| Measure |
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
n=22 Participants
Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
|
Placebo Arm
n=22 Participants
Participants randomized to this study arm received placebo drug for 3 months.
Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 years
n=5 Participants
|
26.5 years
n=7 Participants
|
30.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline,3 monthsPopulation: For some of the assays, some individuals' data was not available.
Neuronal injury measured by Neurofilament Light Chain (NFL). Samples will be analyzed using a digital immunoassay based on a single molecule counting technology.
Outcome measures
| Measure |
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
n=19 Participants
Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
|
Placebo Arm
n=19 Participants
Participants randomized to this study arm received placebo drug for 3 months.
Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
|
|---|---|---|
|
Biomarker Endpoints (NFL)
NFL baseline
|
7.9 picograms per ml
Interval 5.1 to 11.4
|
5.3 picograms per ml
Interval 4.4 to 10.0
|
|
Biomarker Endpoints (NFL)
NFL 1 month
|
6.7 picograms per ml
Interval 3.9 to 12.7
|
8.7 picograms per ml
Interval 4.8 to 13.4
|
|
Biomarker Endpoints (NFL)
NFL 3 months
|
8.2 picograms per ml
Interval 4.1 to 9.5
|
9.7 picograms per ml
Interval 4.6 to 20.0
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: While serum was collected no CRP data or measurements were made or can be made now or in the future.
We will measure serum levels of high sensitivity C-Reactive Protein (CRP)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: While serum was collected, no BDNF data or measurements were collected or can be made now or in the future.
Serum levels of brain derived neurotrophic factor (BDNF)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsDelayed functional recovery will be defined as a Glasgow Outcome Scale Extended (GOSE) \<8 at 3 months. Scores range from 1-8. 8 is Upper good recovery and 1 is death
Outcome measures
| Measure |
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
n=17 Participants
Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
|
Placebo Arm
n=17 Participants
Participants randomized to this study arm received placebo drug for 3 months.
Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
|
|---|---|---|
|
Delayed Functional Recovery
Upper good recovery at 3 months (GOSE=8)
|
16 Participants
|
17 Participants
|
|
Delayed Functional Recovery
Lower good recovery at 3 months (GOSE=7)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsGI distress is measured by number of individuals who experienced it.
Outcome measures
| Measure |
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
n=22 Participants
Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
|
Placebo Arm
n=22 Participants
Participants randomized to this study arm received placebo drug for 3 months.
Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
|
|---|---|---|
|
Gastrointestinal Distress
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All 22 participants were analyzed on an Intention to Treat analysis.
Clinically significant bleeding distress is measured by number of individuals who experienced it.
Outcome measures
| Measure |
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
n=22 Participants
Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
|
Placebo Arm
n=22 Participants
Participants randomized to this study arm received placebo drug for 3 months.
Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
|
|---|---|---|
|
Clinically Significant Bleeding
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCognitive impairment will be defined by a battery of neurocognitive tests including the Montreal Cognitive Assessment (MOCA), Hopkins Verbal Learning Test (HVLT), Trails A and B, Brief Visuospatial Memory Test (BVMT), Stroop Test, Wechsler Test of Adult Reading (WTAR), Brief Test of Attention, (BTA), Wisconsin Card Sorting Test (WCST) and COWAT (Controlled Oral Word Association Test). The WTAR will be used as an estimate of IQ and the neurocognitive test T-scores of interest will be compared against the subject's IQ T-score. The standard deviation (SD) of each T-score is 10. Each of the subject's neurocognitive tests is considered aberrant if it is more than 2 SD below the subject's IQ T-score. A subject is considered cognitively impaired if at least 2 (based on the .05 rule; 5 out of every 100 test scores will be outside of expected range by chance alone) out of the T-scores are aberrant.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsModerate/severe post-concussive symptoms will be defined as the presence of any one or more of the following: headaches, dizziness, general malaise, excessive fatigue, or noise intolerance, irritability, emotional lability, depression, or anxiety, subjective complaints of concentration or memory difficulty, insomnia, reduced tolerance to alcohol, preoccupation with these symptoms and fear of permanent brain damage. These will be self-reported by the patient.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 3 monthsPopulation: Missing blood samples due to loss of follow-up.
Outcome measures
| Measure |
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
n=19 Participants
Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
|
Placebo Arm
n=19 Participants
Participants randomized to this study arm received placebo drug for 3 months.
Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
|
|---|---|---|
|
Glial Fibrillary Acidic Protein (GFAP)
Baseline
|
77.9 picograms per ml
Interval 56.8 to 158.0
|
53.7 picograms per ml
Interval 40.4 to 123.0
|
|
Glial Fibrillary Acidic Protein (GFAP)
1 month
|
51.0 picograms per ml
Interval 41.3 to 91.0
|
87.7 picograms per ml
Interval 59.6 to 118.8
|
|
Glial Fibrillary Acidic Protein (GFAP)
3 month
|
61.2 picograms per ml
Interval 31.2 to 99.7
|
68.4 picograms per ml
Interval 45.7 to 129.0
|
Adverse Events
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3 Polyunsaturated Fatty Acid Treatment Arm
n=22 participants at risk
Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.
|
Placebo Arm
n=22 participants at risk
Participants randomized to this study arm received placebo drug for 3 months.
Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
3/22 • Number of events 3 • 3 months
|
0.00%
0/22 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place