Trial Outcomes & Findings for The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children (NCT NCT01807299)
NCT ID: NCT01807299
Last Updated: 2020-02-28
Results Overview
Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
3 months
Results posted on
2020-02-28
Participant Flow
Participant milestones
| Measure |
Omega-3
Take Omega-3 Only
|
Sedentary (Control)
The sedentary group will be oriented not to make any type of physical training for three months.
|
Placebo + Physical Training
The omega 3 group will receive 2g per day of mineral oil during 90 days treatment
Physical Training
|
Omega 3 + Physical Training
The omega 3 group will receive 2g per day of fish oil during 90 days treatment
Physical Training
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
13
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Omega-3
Take Omega-3 Only
|
Sedentary (Control)
The sedentary group will be oriented not to make any type of physical training for three months.
|
Placebo + Physical Training
The omega 3 group will receive 2g per day of mineral oil during 90 days treatment
Physical Training
|
Omega 3 + Physical Training
The omega 3 group will receive 2g per day of fish oil during 90 days treatment
Physical Training
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
0
|
2
|
Baseline Characteristics
The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children
Baseline characteristics by cohort
| Measure |
Omega-3 Only
n=14 Participants
Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
|
Sedentary (Control)
n=14 Participants
The sedentary group will be oriented not to make any type of physical training for three months.
Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
|
Placebo + Phsycal Training
n=12 Participants
The omega 3 group will receive 2g per day of mineral oil during 90 days treatment
Physical Training
|
Omega 3 + Phsycal Training
n=13 Participants
The omega 3 group will receive 2g per day of fish oil during 90 days treatment
Physical Training
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.27 years
STANDARD_DEVIATION 2.20 • n=99 Participants
|
10.85 years
STANDARD_DEVIATION 2.03 • n=107 Participants
|
10.36 years
STANDARD_DEVIATION 2.71 • n=206 Participants
|
10.55 years
STANDARD_DEVIATION 2.94 • n=7 Participants
|
10.5075 years
STANDARD_DEVIATION 2.47 • n=31 Participants
|
|
Sex: Female, Male
Female
|
00 Participants
n=99 Participants
|
00 Participants
n=107 Participants
|
00 Participants
n=206 Participants
|
00 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
53 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
53 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
00 Participants
n=99 Participants
|
00 Participants
n=107 Participants
|
00 Participants
n=206 Participants
|
00 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
00 Participants
n=99 Participants
|
00 Participants
n=107 Participants
|
00 Participants
n=206 Participants
|
00 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Brazil
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
12 participants
n=206 Participants
|
13 participants
n=7 Participants
|
53 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Conners scale and the child stress scale (ESI)
Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.
Outcome measures
| Measure |
Omega-3 Only
n=14 Participants
Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
|
Sedentary (Control)
n=14 Participants
The sedentary group will be oriented not to make any type of physical training for three months.
|
Placebo + Phsycal Training
n=12 Participants
The omega 3 group will receive 2g per day of mineral oil during 90 days treatment
Physical Training
|
Omega 3 + Phsycal Training
n=13 Participants
The omega 3 group will receive 2g per day of fish oil during 90 days treatment
Physical Training
|
|---|---|---|---|---|
|
Conners Scale
|
36.64 units on a scale
Standard Deviation 12.75
|
42.31 units on a scale
Standard Deviation 12.10
|
40.08 units on a scale
Standard Deviation 14.47
|
36.82 units on a scale
Standard Deviation 7.91
|
Adverse Events
Omega-3 Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sedentary (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo + Phsycal Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Omega 3 + Phsycal Training
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