Trial Outcomes & Findings for Fatty Acid Supplementation in Children With ASD (NCT NCT03550209)
NCT ID: NCT03550209
Last Updated: 2021-08-03
Results Overview
Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Baseline to 90 days post-randomization
Results posted on
2021-08-03
Participant Flow
Participant milestones
| Measure |
LCPUFA Oil Supplement, Low Dose
25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, Medium Dose
50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, High Dose
75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
Canola Oil
Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
13
|
35
|
|
Overall Study
COMPLETED
|
11
|
9
|
11
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
4
|
Reasons for withdrawal
| Measure |
LCPUFA Oil Supplement, Low Dose
25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, Medium Dose
50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, High Dose
75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
Canola Oil
Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
2
|
|
Overall Study
Excluded due to ineligibility after randomization
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Fatty Acid Supplementation in Children With ASD
Baseline characteristics by cohort
| Measure |
LCPUFA Oil Supplement, Low Dose
n=12 Participants
25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, Medium Dose
n=12 Participants
50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, High Dose
n=13 Participants
75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
Canola Oil
n=33 Participants
Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
2-3 years
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Age, Customized
4-6 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African-American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Other or Multiple Races
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Baseline Pre-Specified Biological Signatures (cytokines)
IL-1β
|
0.10 pg/ml
STANDARD_DEVIATION 0.05 • n=99 Participants
|
0.16 pg/ml
STANDARD_DEVIATION 0.25 • n=107 Participants
|
0.07 pg/ml
STANDARD_DEVIATION 0.05 • n=206 Participants
|
0.10 pg/ml
STANDARD_DEVIATION 0.06 • n=7 Participants
|
0.11 pg/ml
STANDARD_DEVIATION 0.04 • n=31 Participants
|
|
Baseline Pre-Specified Biological Signatures (cytokines)
IL-2
|
0.31 pg/ml
STANDARD_DEVIATION 0.12 • n=99 Participants
|
0.55 pg/ml
STANDARD_DEVIATION 0.96 • n=107 Participants
|
0.23 pg/ml
STANDARD_DEVIATION 0.10 • n=206 Participants
|
0.48 pg/ml
STANDARD_DEVIATION 0.47 • n=7 Participants
|
0.39 pg/ml
STANDARD_DEVIATION 0.15 • n=31 Participants
|
|
Baseline Pre-Specified Biological Signatures (cytokines)
IFNγ
|
8.95 pg/ml
STANDARD_DEVIATION 6.40 • n=99 Participants
|
11.22 pg/ml
STANDARD_DEVIATION 10.18 • n=107 Participants
|
9.80 pg/ml
STANDARD_DEVIATION 7.35 • n=206 Participants
|
16.72 pg/ml
STANDARD_DEVIATION 43.17 • n=7 Participants
|
11.67 pg/ml
STANDARD_DEVIATION 3.49 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to 90 days post-randomizationPopulation: 11 participants were not included in analysis due to missing a scheduled blood draw at 90 days post randomization.
Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial
Outcome measures
| Measure |
LCPUFA Oil Supplement, Low Dose
n=9 Participants
25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, Medium Dose
n=9 Participants
50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, High Dose
n=11 Participants
75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
Canola Oil
n=30 Participants
Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
|
|---|---|---|---|---|
|
Bioavailability
EPA
|
1.95 mol%
Standard Deviation 1.04
|
1.80 mol%
Standard Deviation 1.56
|
3.00 mol%
Standard Deviation 2.45
|
0.80 mol%
Standard Deviation 0.33
|
|
Bioavailability
DHA
|
4.33 mol%
Standard Deviation 1.26
|
3.61 mol%
Standard Deviation 1.39
|
4.75 mol%
Standard Deviation 1.76
|
2.46 mol%
Standard Deviation 0.92
|
PRIMARY outcome
Timeframe: Baseline to 90 days post-randomizationAverage number of adverse events per treatment group
Outcome measures
| Measure |
LCPUFA Oil Supplement, Low Dose
n=12 Participants
25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, Medium Dose
n=12 Participants
50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, High Dose
n=13 Participants
75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
Canola Oil
n=33 Participants
Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
|
|---|---|---|---|---|
|
Safety (Adverse Events)
|
4.5 events per person
Standard Deviation 2.35
|
3.33 events per person
Standard Deviation 2.23
|
5.62 events per person
Standard Deviation 2.81
|
3.88 events per person
Standard Deviation 2.53
|
PRIMARY outcome
Timeframe: Baseline to 90 days post-randomizationPopulation: 11 participants were not included in analysis due to missing a scheduled blood draw at 90 days post randomization.
Changes in the biological signatures (IL-1β, IL-2, IFNγ) from baseline to the end of the trial.
Outcome measures
| Measure |
LCPUFA Oil Supplement, Low Dose
n=9 Participants
25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, Medium Dose
n=9 Participants
50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, High Dose
n=11 Participants
75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
Canola Oil
n=30 Participants
Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
|
|---|---|---|---|---|
|
Biological Signatures
IL-1β
|
-0.01 pg/ml
Standard Deviation 0.64
|
-0.02 pg/ml
Standard Deviation 0.38
|
-0.03 pg/ml
Standard Deviation 0.16
|
0.11 pg/ml
Standard Deviation 0.09
|
|
Biological Signatures
IL-2
|
-0.10 pg/ml
Standard Deviation 0.34
|
-0.29 pg/ml
Standard Deviation 0.01
|
-0.11 pg/ml
Standard Deviation 0.26
|
0.01 pg/ml
Standard Deviation 0.24
|
|
Biological Signatures
IFNγ
|
-1.04 pg/ml
Standard Deviation 0.67
|
-1.43 pg/ml
Standard Deviation 0.56
|
2.99 pg/ml
Standard Deviation 0.19
|
-9.77 pg/ml
Standard Deviation 43.92
|
Adverse Events
LCPUFA Oil Supplement, Low Dose
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
LCPUFA Oil Supplement, Medium Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
LCPUFA Oil Supplement, High Dose
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Canola Oil
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LCPUFA Oil Supplement, Low Dose
n=12 participants at risk
25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 25 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, Medium Dose
n=12 participants at risk
50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
LCPUFA Oil Supplement, High Dose
n=13 participants at risk
75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
LCPUFA Oil Supplement: 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
|
Canola Oil
n=33 participants at risk
Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
Canola Oil Placebo: Equal volume of placebo (canola) oil to be administered twice per day by mouth for 90 days
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear
|
16.7%
2/12 • Number of events 2 • Baseline to 90 days post-randomization
|
0.00%
0/12 • Baseline to 90 days post-randomization
|
23.1%
3/13 • Number of events 4 • Baseline to 90 days post-randomization
|
18.2%
6/33 • Number of events 6 • Baseline to 90 days post-randomization
|
|
Eye disorders
Eye
|
8.3%
1/12 • Number of events 1 • Baseline to 90 days post-randomization
|
0.00%
0/12 • Baseline to 90 days post-randomization
|
15.4%
2/13 • Number of events 2 • Baseline to 90 days post-randomization
|
6.1%
2/33 • Number of events 2 • Baseline to 90 days post-randomization
|
|
Gastrointestinal disorders
Gastrointestinal
|
66.7%
8/12 • Number of events 16 • Baseline to 90 days post-randomization
|
83.3%
10/12 • Number of events 14 • Baseline to 90 days post-randomization
|
92.3%
12/13 • Number of events 30 • Baseline to 90 days post-randomization
|
66.7%
22/33 • Number of events 38 • Baseline to 90 days post-randomization
|
|
Infections and infestations
Infectious
|
41.7%
5/12 • Number of events 7 • Baseline to 90 days post-randomization
|
33.3%
4/12 • Number of events 4 • Baseline to 90 days post-randomization
|
61.5%
8/13 • Number of events 9 • Baseline to 90 days post-randomization
|
57.6%
19/33 • Number of events 21 • Baseline to 90 days post-randomization
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
0.00%
0/12 • Baseline to 90 days post-randomization
|
8.3%
1/12 • Number of events 1 • Baseline to 90 days post-randomization
|
15.4%
2/13 • Number of events 2 • Baseline to 90 days post-randomization
|
6.1%
2/33 • Number of events 2 • Baseline to 90 days post-randomization
|
|
Musculoskeletal and connective tissue disorders
Muscular
|
16.7%
2/12 • Number of events 2 • Baseline to 90 days post-randomization
|
16.7%
2/12 • Number of events 2 • Baseline to 90 days post-randomization
|
7.7%
1/13 • Number of events 1 • Baseline to 90 days post-randomization
|
12.1%
4/33 • Number of events 4 • Baseline to 90 days post-randomization
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Baseline to 90 days post-randomization
|
0.00%
0/12 • Baseline to 90 days post-randomization
|
7.7%
1/13 • Number of events 1 • Baseline to 90 days post-randomization
|
6.1%
2/33 • Number of events 2 • Baseline to 90 days post-randomization
|
|
Psychiatric disorders
Psychological
|
41.7%
5/12 • Number of events 6 • Baseline to 90 days post-randomization
|
33.3%
4/12 • Number of events 5 • Baseline to 90 days post-randomization
|
53.8%
7/13 • Number of events 9 • Baseline to 90 days post-randomization
|
36.4%
12/33 • Number of events 17 • Baseline to 90 days post-randomization
|
|
Renal and urinary disorders
Genital
|
8.3%
1/12 • Number of events 1 • Baseline to 90 days post-randomization
|
0.00%
0/12 • Baseline to 90 days post-randomization
|
7.7%
1/13 • Number of events 1 • Baseline to 90 days post-randomization
|
3.0%
1/33 • Number of events 1 • Baseline to 90 days post-randomization
|
|
Respiratory, thoracic and mediastinal disorders
Nose
|
41.7%
5/12 • Number of events 6 • Baseline to 90 days post-randomization
|
25.0%
3/12 • Number of events 3 • Baseline to 90 days post-randomization
|
30.8%
4/13 • Number of events 5 • Baseline to 90 days post-randomization
|
12.1%
4/33 • Number of events 5 • Baseline to 90 days post-randomization
|
|
Skin and subcutaneous tissue disorders
Skin
|
16.7%
2/12 • Number of events 3 • Baseline to 90 days post-randomization
|
16.7%
2/12 • Number of events 2 • Baseline to 90 days post-randomization
|
15.4%
2/13 • Number of events 2 • Baseline to 90 days post-randomization
|
18.2%
6/33 • Number of events 7 • Baseline to 90 days post-randomization
|
|
Musculoskeletal and connective tissue disorders
Mouth
|
0.00%
0/12 • Baseline to 90 days post-randomization
|
0.00%
0/12 • Baseline to 90 days post-randomization
|
0.00%
0/13 • Baseline to 90 days post-randomization
|
9.1%
3/33 • Number of events 4 • Baseline to 90 days post-randomization
|
|
Respiratory, thoracic and mediastinal disorders
Chest
|
25.0%
3/12 • Number of events 3 • Baseline to 90 days post-randomization
|
41.7%
5/12 • Number of events 6 • Baseline to 90 days post-randomization
|
38.5%
5/13 • Number of events 5 • Baseline to 90 days post-randomization
|
27.3%
9/33 • Number of events 9 • Baseline to 90 days post-randomization
|
|
Nervous system disorders
Energy
|
25.0%
3/12 • Number of events 3 • Baseline to 90 days post-randomization
|
16.7%
2/12 • Number of events 3 • Baseline to 90 days post-randomization
|
0.00%
0/13 • Baseline to 90 days post-randomization
|
12.1%
4/33 • Number of events 4 • Baseline to 90 days post-randomization
|
|
Nervous system disorders
Sleep
|
33.3%
4/12 • Number of events 4 • Baseline to 90 days post-randomization
|
0.00%
0/12 • Baseline to 90 days post-randomization
|
15.4%
2/13 • Number of events 2 • Baseline to 90 days post-randomization
|
18.2%
6/33 • Number of events 6 • Baseline to 90 days post-randomization
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place