Trial Outcomes & Findings for Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG) (NCT NCT01248728)
NCT ID: NCT01248728
Last Updated: 2025-07-16
Results Overview
The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity. PDDBI Autism Composite Scale Range: Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity) The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score. Mean change between baseline and week 24 is reported. A negative change indicates improvement
COMPLETED
PHASE2
38 participants
Baseline and 24 Weeks
2025-07-16
Participant Flow
Participants were recruited from the hospital clinical database, as well as presentations at local conferences and media. Diagnosis was established using the Diagnostic and Statistical Manual, Fourth Edition for an Autism Spectrum Disorder supported by the Autism Diagnostic Observations Schedule and the Autism Diagnostic Interview - Revised.
Participants were randomized to the two arms in a 1:1 fashion by the pharmacy, based on a randomization schedule produced by the study biostatistician. They were stratified into one of four strata based on the PDDBI score obtained at screening (four quartiles).
Participant milestones
| Measure |
Omega-3 Fatty Acids
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
|
Placebo
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Omega-3 Fatty Acids
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
|
Placebo
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG)
Baseline characteristics by cohort
| Measure |
Omega-3 Fatty Acids
n=19 Participants
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
|
Placebo
n=19 Participants
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 WeeksPopulation: 1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity. PDDBI Autism Composite Scale Range: Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity) The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score. Mean change between baseline and week 24 is reported. A negative change indicates improvement
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=18 Participants
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
|
Placebo
n=19 Participants
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
|
|---|---|---|
|
Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score
|
-4.5 units on a scale
Interval -8.5 to -0.6
|
-6.4 units on a scale
Interval -10.2 to -2.7
|
PRIMARY outcome
Timeframe: Baseline and 24 WeeksPopulation: 1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
The BASC-2 externalizing problems composite measures hyperactivity and aggressive behaviours. Primary Outcome domain: Externalizing Problems composite Externalizing Problems Composite T-Score Range: Minimum Range: 10 (lower externalizing problems) Maximum Range: 120 (higher externalizing problems) The Externalizing Problems composite is computed from the sum of t-scores from the hyperactivity and aggression subscales then converted into the externalizing problems composite t-score. Mean change between baseline and week 24 is reported. A negative change indicates improvement.
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=18 Participants
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
|
Placebo
n=19 Participants
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
|
|---|---|---|
|
Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite
|
3.2 units on a scale
Interval -0.5 to 6.9
|
-3.0 units on a scale
Interval -6.6 to 0.6
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
The CGI-I is a seven-point scale that provides a clinician rating of global improvement and as such is already inherently a measure of change. It requires the clinician to assess the degree to which the participant's illness has improved or worsened relative to a baseline state before the intervention. Change is rated as: 0- Not assessed 1. Very Much Improved 2. Much Improved 3. Minimally Improved 4. No Change 5. Minimally Worse 6. Much Worse 7. Very Much Worse Participants are classified as responders if their CGI-I score was 1 or 2 and non-responders for CGI-I scores of 3 to 7.
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=18 Participants
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
|
Placebo
n=19 Participants
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
|
|---|---|---|
|
Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I)
|
12 participants classified as responders
|
12 participants classified as responders
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksPopulation: 1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
The VABS is a measure of adaptive behavior in daily settings. Secondary measure domain: The adaptive functioning composite describes an individuals overall functioning Adaptive Behaviour Composite Standard Score Range: Minimum range: 20 (low adaptive functioning) Maximum range: 160 (high adaptive functioning) The adaptive behaviour composite standard score is computed from the sum of standard scores from the communication, daily living skills, socialization and motor skills domains and converted into the adaptive behavior composite standard score. Change in the adaptive behaviour composite standard score from baseline to week 24 is reported. Positive change indicates improvement.
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=18 Participants
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
|
Placebo
n=19 Participants
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
|
|---|---|---|
|
Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite
|
2.8 units on a scale
Interval 0.2 to 5.3
|
-0.2 units on a scale
Interval -2.6 to 2.2
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksPopulation: 1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
The PLS-4 is a language measure that provides a global assessment of a child's language functioning abilities, receptive and expressive language. Secondary outcome measure domain: Total language standard score Total Language Standard Score Range: Minimum range: 50 (lower language abilities) Maximum range: 150 (higher language abilities) The total language standard score is computed from a sum of the auditory comprehension and expressive communication standard scores, then converted into the total language standard score. Change of total language standard scores from baseline to week 24 is reported. Positive change indicates improvement
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=18 Participants
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
|
Placebo
n=19 Participants
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
|
|---|---|---|
|
Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language
|
0.7 units on a scale
Interval -2.7 to 4.1
|
-0.6 units on a scale
Interval -3.7 to 2.6
|
Adverse Events
Omega-3 Fatty Acids
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3 Fatty Acids
n=19 participants at risk
Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.
Omega-3 Fatty Acids: Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.
|
Placebo
n=19 participants at risk
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
|
|---|---|---|
|
Psychiatric disorders
Overactivity
|
15.8%
3/19 • Number of events 3
|
0.00%
0/19
|
|
General disorders
Decreased Energy
|
15.8%
3/19 • Number of events 4
|
10.5%
2/19 • Number of events 2
|
|
Psychiatric disorders
Social Communicative Intent Loss
|
5.3%
1/19 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Staring Spell
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Psychiatric disorders
Increased Emotional Lability
|
5.3%
1/19 • Number of events 1
|
10.5%
2/19 • Number of events 3
|
|
Psychiatric disorders
Increased Irritability/Anger/Aggression
|
36.8%
7/19 • Number of events 10
|
10.5%
2/19 • Number of events 4
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Psychiatric disorders
Stuttering
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Increased Appetite
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
31.6%
6/19 • Number of events 7
|
10.5%
2/19 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased Dietary Variety
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.8%
3/19 • Number of events 6
|
15.8%
3/19 • Number of events 4
|
|
Gastrointestinal disorders
Regurgitation
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Vomiting
|
21.1%
4/19 • Number of events 4
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
26.3%
5/19 • Number of events 5
|
42.1%
8/19 • Number of events 9
|
|
Gastrointestinal disorders
Constipation
|
31.6%
6/19 • Number of events 7
|
31.6%
6/19 • Number of events 7
|
|
Eye disorders
Eye Swelling
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Eye disorders
Nearsightedness
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Surgical and medical procedures
Eye Surgery
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Ear and labyrinth disorders
Earache
|
15.8%
3/19 • Number of events 3
|
0.00%
0/19
|
|
Eye disorders
Red Eyes
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nose Bleed
|
0.00%
0/19
|
15.8%
3/19 • Number of events 3
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.3%
1/19 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19 • Number of events 3
|
15.8%
3/19 • Number of events 4
|
|
Renal and urinary disorders
Daytime Wetting
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Renal and urinary disorders
Pain on Urination
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Renal and urinary disorders
Change in Urine Colour
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Right Leg Internal Rotation
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Left Knee Injury
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
31.6%
6/19 • Number of events 10
|
47.4%
9/19 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.5%
2/19 • Number of events 2
|
15.8%
3/19 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Bruising
|
15.8%
3/19 • Number of events 4
|
5.3%
1/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.3%
1/19 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Flaky Scalp
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Infection
|
84.2%
16/19 • Number of events 23
|
73.7%
14/19 • Number of events 24
|
|
Infections and infestations
Fever
|
21.1%
4/19 • Number of events 4
|
21.1%
4/19 • Number of events 5
|
|
Infections and infestations
Ear Infection
|
5.3%
1/19 • Number of events 1
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.3%
1/19 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Infections and infestations
Skin Infection
|
5.3%
1/19 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Hand Mouth Foot Disease
|
0.00%
0/19
|
5.3%
1/19 • Number of events 2
|
|
Infections and infestations
Roseola
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Initial Insomnia
|
26.3%
5/19 • Number of events 6
|
21.1%
4/19 • Number of events 4
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/19
|
15.8%
3/19 • Number of events 3
|
|
Nervous system disorders
Mid-cycle Insomnia
|
15.8%
3/19 • Number of events 6
|
10.5%
2/19 • Number of events 3
|
|
Nervous system disorders
Early Awakening
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
Non-restorative Sleep
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
Nightmares
|
5.3%
1/19 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
Additional Information
Dr. Evdokia Anagnostou
Holland Bloorview Kids Rehabilitation Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place