Autism Spectrum Disorder
Conditions
Brief summary
The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms.
Detailed description
Children with ASD suffer from both mental and physical symptoms that affect quality of life and severely disrupt family well-being. The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but the efficacy remains unproven.
Interventions
25 mg/kg, 50 mg/kg, or 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
DIETARY_SUPPLEMENTCanola Oil Placebo
Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Sarah Keim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Age 2-6 years old * ASD diagnosis at Nationwide Children's Hospital within the prior 6 months * English is primary language
Exclusion criteria
* Fatty acid supplementation in the past 6 months * Consumes fatty fish more than 3 times per week * Still breastfeeding or formula feeding * Bleeding disorder * Quadriparesis * Deafness * Blindness * Seizure disorder diagnosis * Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angelman Syndromes, Tuberous Sclerosis * Feeding problems precluding consumption of the supplement * Ingredient allergy (canola, fish, or borage seed) * Planned surgeries scheduled within the time frame of trial participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite | Baseline to 90 days post randomization. | Change in PDDBI Autism Composite raw score. This scale measures the severity and nature of autism symptoms. Autism Composite raw scores range -31 to 262. Higher scores indicate greater severity. We omitted the Semantic/Pragmatic Problems subscale from the calculation of the PDD autism composite raw score because including that subscale penalizes children who are nonverbal at baseline but gain language during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems | Baseline to 90 days post randomization. | Change in PDDBI Aggressiveness Problems raw score. Aggressiveness domain looks at self-directed aggressive behaviors, incongruous negative affect, problems when caregiver returns from an outing, aggressiveness towards others, and overall temperament problems. Aggressiveness raw scores range from 0-60; higher scores are indicative of more aggressiveness. |
| Preschool Language Scales - 5 (PLS-5) Auditory Comprehension | Baseline to 90 days post randomization. | Changes in Auditory Comprehension raw score. Higher scores represent better child comprehension of language. Raw scores range 0-65 for Auditory Comprehension. |
| Childhood Autism Rating Scale (CARS2) (2nd ed.) | Baseline to 90 days post randomization. | Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60. |
| Autism Impact Measure - Total | Baseline to 90 days post randomization. | The Autism Impact Measure is a newly developed instrument for measuring change in Autism Spectrum Disorder related behaviors. (Houghton, Journal of Autism and Developmental Disorders, 2019). The Autism Impact Measure (AIM) Total Score represents the overall level of autism symptom impact across all measured domains, incorporating both the frequency and impact of symptoms. The possible range of raw scores for the AIM Total is 41 to 410. This scale measures the global severity and pervasiveness of autism-related behaviors, with higher scores indicating greater symptom impact and worse functioning, and lower scores reflecting fewer symptoms and better functioning. |
| Preschool Language Scales-5 Expressive Communication | Baseline (day 0) to end of trial (90 days) | Changes in Expressive Communication raw score. Higher scores represent better child ability to communicate with others. Raw scores range 0-67. |
| Preschool Language Scales-5 Total Language | Baseline (day 0) to end of trial (90 days) | Changes in Total Language raw score (sum of Auditory Comprehension and Expressive Communication raw scores). Higher scores represent better communication ability. Raw scores range 0-131. |
| Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite | Baseline to 90 days post randomization (End of Trial) | Change in adaptive behavior composite score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-634. |
| Autism Impact Measure - Communication | Baseline to 90 days post randomization. | The Autism Impact Measure (AIM) Communication Score evaluates expressive and receptive communication skills, taking into account both the frequency of communication challenges and their impact on functioning. The possible range of raw scores for this scale is 12 to 60. It measures how effectively an individual communicates, with higher scores indicating greater communication difficulties and worse functioning. |
| Autism Impact Measure - Atypical Behavior | Baseline to 90 days post randomization. | The Autism Impact Measure (AIM) Atypical Behavior Score captures unusual sensory responses, emotional regulation difficulties, and other atypical behaviors, assessing both how often these behaviors occur and how much they interfere with daily life. The possible range of raw scores for this scale is 12 to 60. It measures the presence and impact of atypical behaviors, with higher scores indicating more frequent or intense atypical behaviors and poorer functioning. |
| Autism Impact Measure - Social Reciprocity | Baseline to 90 days post randomization. | The Autism Impact Measure (AIM) Social Reciprocity Score assesses social engagement, emotional responsiveness, and reciprocal interactions, considering both the frequency and impact of social difficulties. The possible range of raw scores for this scale is 10 to 50. It measures social responsiveness and connectedness, with higher scores indicating greater social difficulty and worse functioning. |
| Autism Impact Measure - Peer Interaction | Baseline to 90 days post randomization. | The Autism Impact Measure (AIM) Peer Interaction Score evaluates social interest, initiation, and quality of interactions with peers, capturing both how often behaviors occur and how impactful they are. The possible range of raw scores for this scale is 8 to 40. It measures the child's ability to interact appropriately with peers, with higher scores indicating more challenges in peer relationships and worse functioning. for this scale is 10 to 50. Higher scores indicating greater social difficulty and worse functioning. |
| Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication | Baseline to 90 days post randomization (End of Trial) | Change in communication score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-148. |
| Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization | Baseline to 90 days post randomization (End of Trial) | Change in socialization score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-174. |
| Autism Impact Measure - Restricted Behavior | Baseline to 90 days post randomization. | The Autism Impact Measure (AIM) Repetitive Behavior Score assesses repetitive movements, rituals, and restricted interests, capturing both how often these behaviors occur and how much they affect daily life. The possible range of raw scores for this scale is 16 to 80. It measures the frequency and impact of repetitive behaviors, with higher scores reflecting more frequent and disruptive behaviors and poorer functioning. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GLA + EPA + DHA Group 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (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 | 48 |
| Canola Oil Group Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight. | 48 |
| Total | 96 |
Baseline characteristics
| Characteristic | Canola Oil Group | Total | GLA + EPA + DHA Group |
|---|---|---|---|
| Age, Categorical <=18 years | 48 Participants | 96 Participants | 48 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 89 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 20 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 28 Participants | 56 Participants | 28 Participants |
| Region of Enrollment United States | 48 participants | 96 participants | 48 participants |
| Sex: Female, Male Female | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Male | 37 Participants | 74 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 45 / 48 | 46 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
Change in PDDBI Autism Composite raw score. This scale measures the severity and nature of autism symptoms. Autism Composite raw scores range -31 to 262. Higher scores indicate greater severity. We omitted the Semantic/Pragmatic Problems subscale from the calculation of the PDD autism composite raw score because including that subscale penalizes children who are nonverbal at baseline but gain language during the study.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite | Baseline | 115.5 raw score on a scale | Standard Deviation 32.5 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite | 90 days post randomization (End of Trial) | 98.1 raw score on a scale | Standard Deviation 34.1 |
| Canola Oil | Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite | 90 days post randomization (End of Trial) | 91.4 raw score on a scale | Standard Deviation 36.1 |
| Canola Oil | Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite | Baseline | 106.5 raw score on a scale | Standard Deviation 34.6 |
Secondary
Autism Impact Measure - Atypical Behavior
The Autism Impact Measure (AIM) Atypical Behavior Score captures unusual sensory responses, emotional regulation difficulties, and other atypical behaviors, assessing both how often these behaviors occur and how much they interfere with daily life. The possible range of raw scores for this scale is 12 to 60. It measures the presence and impact of atypical behaviors, with higher scores indicating more frequent or intense atypical behaviors and poorer functioning.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Atypical Behavior | Baseline | 30.2 score on a scale | Standard Deviation 9.6 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Atypical Behavior | 90 days post randomization (End of Trial) | 28.7 score on a scale | Standard Deviation 9.5 |
| Canola Oil | Autism Impact Measure - Atypical Behavior | Baseline | 29.5 score on a scale | Standard Deviation 9.4 |
| Canola Oil | Autism Impact Measure - Atypical Behavior | 90 days post randomization (End of Trial) | 26 score on a scale | Standard Deviation 9.5 |
Secondary
Autism Impact Measure - Communication
The Autism Impact Measure (AIM) Communication Score evaluates expressive and receptive communication skills, taking into account both the frequency of communication challenges and their impact on functioning. The possible range of raw scores for this scale is 12 to 60. It measures how effectively an individual communicates, with higher scores indicating greater communication difficulties and worse functioning.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Communication | Baseline | 36.4 score on a scale | Standard Deviation 11.1 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Communication | 90 days post randomization (End of Trial) | 32.9 score on a scale | Standard Deviation 11.4 |
| Canola Oil | Autism Impact Measure - Communication | Baseline | 37.1 score on a scale | Standard Deviation 10.1 |
| Canola Oil | Autism Impact Measure - Communication | 90 days post randomization (End of Trial) | 35.4 score on a scale | Standard Deviation 10.4 |
Secondary
Autism Impact Measure - Peer Interaction
The Autism Impact Measure (AIM) Peer Interaction Score evaluates social interest, initiation, and quality of interactions with peers, capturing both how often behaviors occur and how impactful they are. The possible range of raw scores for this scale is 8 to 40. It measures the child's ability to interact appropriately with peers, with higher scores indicating more challenges in peer relationships and worse functioning. for this scale is 10 to 50. Higher scores indicating greater social difficulty and worse functioning.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Peer Interaction | Baseline | 26.8 score on a scale | Standard Deviation 6.2 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Peer Interaction | 90 days post randomization (End of Trial) | 25.4 score on a scale | Standard Deviation 7 |
| Canola Oil | Autism Impact Measure - Peer Interaction | Baseline | 25.5 score on a scale | Standard Deviation 7.9 |
| Canola Oil | Autism Impact Measure - Peer Interaction | 90 days post randomization (End of Trial) | 24.3 score on a scale | Standard Deviation 8.4 |
Secondary
Autism Impact Measure - Restricted Behavior
The Autism Impact Measure (AIM) Repetitive Behavior Score assesses repetitive movements, rituals, and restricted interests, capturing both how often these behaviors occur and how much they affect daily life. The possible range of raw scores for this scale is 16 to 80. It measures the frequency and impact of repetitive behaviors, with higher scores reflecting more frequent and disruptive behaviors and poorer functioning.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Restricted Behavior | Baseline | 43.3 score on a scale | Standard Deviation 11.3 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Restricted Behavior | 90 days post randomization (End of Trial) | 40.3 score on a scale | Standard Deviation 12.4 |
| Canola Oil | Autism Impact Measure - Restricted Behavior | Baseline | 43 score on a scale | Standard Deviation 14.3 |
| Canola Oil | Autism Impact Measure - Restricted Behavior | 90 days post randomization (End of Trial) | 38.3 score on a scale | Standard Deviation 12.3 |
Secondary
Autism Impact Measure - Social Reciprocity
The Autism Impact Measure (AIM) Social Reciprocity Score assesses social engagement, emotional responsiveness, and reciprocal interactions, considering both the frequency and impact of social difficulties. The possible range of raw scores for this scale is 10 to 50. It measures social responsiveness and connectedness, with higher scores indicating greater social difficulty and worse functioning.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Social Reciprocity | Baseline | 26.8 score on a scale | Standard Deviation 6.2 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Social Reciprocity | 90 days post randomization (End of Trial) | 25.4 score on a scale | Standard Deviation 7 |
| Canola Oil | Autism Impact Measure - Social Reciprocity | Baseline | 25.5 score on a scale | Standard Deviation 7.9 |
| Canola Oil | Autism Impact Measure - Social Reciprocity | 90 days post randomization (End of Trial) | 24.3 score on a scale | Standard Deviation 8.4 |
Secondary
Autism Impact Measure - Total
The Autism Impact Measure is a newly developed instrument for measuring change in Autism Spectrum Disorder related behaviors. (Houghton, Journal of Autism and Developmental Disorders, 2019). The Autism Impact Measure (AIM) Total Score represents the overall level of autism symptom impact across all measured domains, incorporating both the frequency and impact of symptoms. The possible range of raw scores for the AIM Total is 41 to 410. This scale measures the global severity and pervasiveness of autism-related behaviors, with higher scores indicating greater symptom impact and worse functioning, and lower scores reflecting fewer symptoms and better functioning.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Total | 90 days post randomization (End of Trial) | 207.9 score on a scale | Standard Deviation 50.6 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Autism Impact Measure - Total | Baseline | 222.4 score on a scale | Standard Deviation 45.5 |
| Canola Oil | Autism Impact Measure - Total | 90 days post randomization (End of Trial) | 200.0 score on a scale | Standard Deviation 55.7 |
| Canola Oil | Autism Impact Measure - Total | Baseline | 215.6 score on a scale | Standard Deviation 55.5 |
Secondary
Childhood Autism Rating Scale (CARS2) (2nd ed.)
Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Childhood Autism Rating Scale (CARS2) (2nd ed.) | Baseline | 32.9 raw score on a scale | Standard Deviation 8.1 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Childhood Autism Rating Scale (CARS2) (2nd ed.) | 90 days post randomization (End of Trial) | 32.4 raw score on a scale | Standard Deviation 7.5 |
| Canola Oil | Childhood Autism Rating Scale (CARS2) (2nd ed.) | Baseline | 30.9 raw score on a scale | Standard Deviation 7.5 |
| Canola Oil | Childhood Autism Rating Scale (CARS2) (2nd ed.) | 90 days post randomization (End of Trial) | 31.5 raw score on a scale | Standard Deviation 7.8 |
Secondary
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems
Change in PDDBI Aggressiveness Problems raw score. Aggressiveness domain looks at self-directed aggressive behaviors, incongruous negative affect, problems when caregiver returns from an outing, aggressiveness towards others, and overall temperament problems. Aggressiveness raw scores range from 0-60; higher scores are indicative of more aggressiveness.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems | 90 days post randomization (End of Trial) | 23.1 raw score on a scale | Standard Deviation 12.6 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems | Baseline | 26.7 raw score on a scale | Standard Deviation 13.2 |
| Canola Oil | Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems | Baseline | 26.5 raw score on a scale | Standard Deviation 13.8 |
| Canola Oil | Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems | 90 days post randomization (End of Trial) | 23.8 raw score on a scale | Standard Deviation 13.4 |
Secondary
Preschool Language Scales-5 Expressive Communication
Changes in Expressive Communication raw score. Higher scores represent better child ability to communicate with others. Raw scores range 0-67.
Time frame: Baseline (day 0) to end of trial (90 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Preschool Language Scales-5 Expressive Communication | baseline day 0 | 31.0 raw score on a scale | Standard Deviation 11.5 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Preschool Language Scales-5 Expressive Communication | end of trial day 90 | 31.2 raw score on a scale | Standard Deviation 12.2 |
| Canola Oil | Preschool Language Scales-5 Expressive Communication | baseline day 0 | 28.8 raw score on a scale | Standard Deviation 10.5 |
| Canola Oil | Preschool Language Scales-5 Expressive Communication | end of trial day 90 | 30.7 raw score on a scale | Standard Deviation 11.9 |
Secondary
Preschool Language Scales - 5 (PLS-5) Auditory Comprehension
Changes in Auditory Comprehension raw score. Higher scores represent better child comprehension of language. Raw scores range 0-65 for Auditory Comprehension.
Time frame: Baseline to 90 days post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Preschool Language Scales - 5 (PLS-5) Auditory Comprehension | 90 days post randomization (End of Trial) | 30.3 raw score on a scale | Standard Deviation 14.9 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Preschool Language Scales - 5 (PLS-5) Auditory Comprehension | Baseline | 29.4 raw score on a scale | Standard Deviation 14.3 |
| Canola Oil | Preschool Language Scales - 5 (PLS-5) Auditory Comprehension | Baseline | 28.9 raw score on a scale | Standard Deviation 13.6 |
| Canola Oil | Preschool Language Scales - 5 (PLS-5) Auditory Comprehension | 90 days post randomization (End of Trial) | 30.3 raw score on a scale | Standard Deviation 13.8 |
Secondary
Preschool Language Scales-5 Total Language
Changes in Total Language raw score (sum of Auditory Comprehension and Expressive Communication raw scores). Higher scores represent better communication ability. Raw scores range 0-131.
Time frame: Baseline (day 0) to end of trial (90 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Preschool Language Scales-5 Total Language | baseline day 0 | 60.4 raw score on a scale | Standard Deviation 25.3 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Preschool Language Scales-5 Total Language | end of trial day 90 | 61.5 raw score on a scale | Standard Deviation 26.6 |
| Canola Oil | Preschool Language Scales-5 Total Language | end of trial day 90 | 61.0 raw score on a scale | Standard Deviation 25.2 |
| Canola Oil | Preschool Language Scales-5 Total Language | baseline day 0 | 57.6 raw score on a scale | Standard Deviation 23.2 |
Secondary
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite
Change in adaptive behavior composite score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-634.
Time frame: Baseline to 90 days post randomization (End of Trial)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite | Baseline | 280.3 raw score on a scale | Standard Deviation 99.89 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite | 90 days post randomization (End of Trial) | 303.6 raw score on a scale | Standard Deviation 116.9 |
| Canola Oil | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite | Baseline | 277.1 raw score on a scale | Standard Deviation 114.8 |
| Canola Oil | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite | 90 days post randomization (End of Trial) | 290.0 raw score on a scale | Standard Deviation 120.3 |
Secondary
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication
Change in communication score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-148.
Time frame: Baseline to 90 days post randomization (End of Trial)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication | Baseline | 74.2 raw score on a scale | Standard Deviation 39.4 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication | 90 days post randomization (End of Trial) | 80 raw score on a scale | Standard Deviation 42.6 |
| Canola Oil | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication | Baseline | 67.9 raw score on a scale | Standard Deviation 39.6 |
| Canola Oil | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication | 90 days post randomization (End of Trial) | 73.4 raw score on a scale | Standard Deviation 39.4 |
Secondary
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization
Change in socialization score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-174.
Time frame: Baseline to 90 days post randomization (End of Trial)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization | Baseline | 64.4 raw score on a scale | Standard Deviation 30 |
| Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization | 90 days post randomization (End of Trial) | 67.9 raw score on a scale | Standard Deviation 31.8 |
| Canola Oil | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization | Baseline | 66.1 raw score on a scale | Standard Deviation 34.8 |
| Canola Oil | Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization | 90 days post randomization (End of Trial) | 68.5 raw score on a scale | Standard Deviation 35.8 |