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| ID | Type | Description | Link |
|---|---|---|---|
| R33AT009632 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement | Experimental | 25 mg/kg, 50 mg/kg, or 75 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 |
|
| Canola Oil | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCPUFA Oil Supplement | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 90 days post randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 90 days post randomization (End of Trial) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Keim, PhD | Nationwide Children's Hospital | Principal Investigator |
| Lynette Rogers, PhD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Canola Oil Group | Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | raw score on a scale | Baseline to 90 days post randomization. |
|
90 days
Safety Monitoring Uniform Report Form (SMURF)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest or breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
This trial may have been underpowered to detect a clinically meaningful effect on autism symptoms. 90 days is short and this may have precluded observing effects. The focus on children with confirmed autism diagnoses and English language limit the generalizability to older or non-English speaking children or those with subclinical autistic traits. The single site-specific context may not be representative of other settings. Compliance with consuming the daily supplement was challenging.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Keim | Nationwide Children's Hospital | 614-722-2000 | sarah.keim@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2024 | Jan 29, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 12, 2024 | Jan 29, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Canola Oil Placebo | Dietary Supplement | 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 |
|
| 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. | Baseline to 90 days post randomization. |
| 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. | Baseline to 90 days post randomization. |
| Childhood Autism Rating Scale (CARS2) (2nd ed.) | Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60. | Baseline to 90 days post randomization. |
| 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. | Baseline to 90 days post randomization. |
| 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. | Baseline (day 0) to end of trial (90 days) |
| 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. | Baseline (day 0) to end of trial (90 days) |
| 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. | Baseline to 90 days post randomization. |
| 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. | Baseline to 90 days post randomization. |
| 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. | Baseline to 90 days post randomization. |
| 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. | Baseline to 90 days post randomization. |
| 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. | Baseline to 90 days post randomization. |
| 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. | Baseline to 90 days post randomization (End of Trial) |
| 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. | Baseline to 90 days post randomization (End of Trial) |
| Canola Oil Group |
Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Canola Oil | 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 Canola 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | raw score on a scale | Baseline to 90 days post randomization (End of Trial) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | raw score on a scale | Baseline to 90 days post randomization. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | raw score on a scale | Baseline to 90 days post randomization. |
|
|
|
| Secondary | Childhood Autism Rating Scale (CARS2) (2nd ed.) | Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60. | Posted | Mean | Standard Deviation | raw score on a scale | Baseline to 90 days post randomization. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 90 days post randomization. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | raw score on a scale | Baseline (day 0) to end of trial (90 days) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | raw score on a scale | Baseline (day 0) to end of trial (90 days) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 90 days post randomization. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 90 days post randomization. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 90 days post randomization. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 90 days post randomization. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 90 days post randomization. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | raw score on a scale | Baseline to 90 days post randomization (End of Trial) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | raw score on a scale | Baseline to 90 days post randomization (End of Trial) |
|
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|
| 0 |
| 48 |
| 0 |
| 48 |
| 45 |
| 48 |
| EG001 | Canola Oil Group | Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight. | 0 | 48 | 0 | 48 | 46 | 48 |
| Ears | Ear and labyrinth disorders | Systematic Assessment |
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| Energy level | Metabolism and nutrition disorders | Systematic Assessment |
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| Eyes | Eye disorders | Systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | Systematic Assessment |
|
| Gastrointestinal and eating | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Heart | Cardiac disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Mouth lips teeth | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Musculoskeletal and movement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nose, sinus, throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Psychological | Psychiatric disorders | Systematic Assessment |
|
| Skin or hair | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sleep | Psychiatric disorders | Systematic Assessment |
|
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