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| ID | Type | Description | Link |
|---|---|---|---|
| R61AT009632 | 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 purpose of this study is to examine how fatty acid supplementation alters biological signatures in children with ASD
Children with Autism Spectrum Disorder (ASD) suffer from both mental and physical symptoms that affect their quality of life and severely disrupt family well-being. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but their efficacy remains unproven. The objective of the proposed protocol is to quantify the impact of Omega 3-6 on pre-specified biological signatures. The hypotheses were formulated based on data from the investigators previous studies and other published data which suggest that the inflammatory markers, IL-1β, IL-2, and IFNγ are consistently elevated in children with ASD and decreases in these markers correlate with ASD symptom improvement. The investigators long-term goal is to identify effective treatments for ASD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCPUFA Oil Supplement, Low Dose | Experimental | 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 | Experimental | 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 | Experimental | 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 | 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 |
|---|---|---|
| Bioavailability | Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial | Baseline to 90 days post-randomization |
| Safety (Adverse Events) | Average number of adverse events per treatment group | Baseline to 90 days post-randomization |
| Biological Signatures | Changes in the biological signatures (IL-1β, IL-2, IFNγ) from baseline to the end of the trial. | Baseline to 90 days post-randomization |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35013866 | Derived | Keim SA, Jude A, Smith K, Khan AQ, Coury DL, Rausch J, Udaipuria S, Norris M, Bartram LR, Narayanan AR, Rogers LK. Randomized Controlled Trial of Omega-3 and -6 Fatty Acid Supplementation to Reduce Inflammatory Markers in Children with Autism Spectrum Disorder. J Autism Dev Disord. 2022 Dec;52(12):5342-5355. doi: 10.1007/s10803-021-05396-9. Epub 2022 Jan 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
72 participants were randomized into the study, but only 70 participants were included in analysis. Two participants who were randomized to receive canola oil (placebo) were found to be ineligible after randomization. These two participants were unenrolled from the study by the Principal Investigators and were not included in any analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | LCPUFA Oil Supplement, Medium Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Bioavailability | Group differences in bioavailability; each fatty acid as a percent of total erythrocyte fatty acids at the end of the trial | 11 participants were not included in analysis due to missing a scheduled blood draw at 90 days post randomization. | Posted | Mean | Standard Deviation | mol% | Baseline to 90 days post-randomization |
|
Baseline to 90 days post-randomization
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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 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear | Ear and labyrinth disorders | Systematic Assessment | Includes ear infection, poor hearing, and fluid in ears. |
There were initially unanticipated obstacles in identifying enough patients because the ADOS scores were not consistently available for all patients in the electronic medical record system (EPIC), and this score served as part of the eligibility criteria. This problem was solved, and our recruitment pace rebounded, we went from approximately 2-3 enrollments per month to 6.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Keim | Nationwide Children's Hospital | 1-800-792-8401 | 52849 | 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 | May 22, 2018 | Jan 21, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2018 | Jan 17, 2020 | 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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Quadruple
| 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 |
|
| Withdrawal by Subject |
|
| Excluded due to ineligibility after randomization |
|
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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline Pre-Specified Biological Signatures (cytokines) | A blood draw was completed at the first study visit prior to beginning any study interventions. This blood draw was used to collect baseline data for pre-specified biological signatures. | Mean | Standard Deviation | pg/ml |
|
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
| OG002 | 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 |
| OG003 | 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 |
|
|
| Primary | Safety (Adverse Events) | Average number of adverse events per treatment group | Posted | Mean | Standard Deviation | events per person | Baseline to 90 days post-randomization |
|
|
|
| Primary | Biological Signatures | Changes in the biological signatures (IL-1β, IL-2, IFNγ) from baseline to the end of the trial. | 11 participants were not included in analysis due to missing a scheduled blood draw at 90 days post randomization. | Posted | Mean | Standard Deviation | pg/ml | Baseline to 90 days post-randomization |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | 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 | 0 | 12 | 0 | 12 | 11 | 12 |
| EG002 | 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 | 0 | 13 | 0 | 13 | 13 | 13 |
| EG003 | 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 | 0 | 33 | 0 | 33 | 31 | 33 |
|
| Eye | Eye disorders | Systematic Assessment | Includes eye irritation and conjunctivitis. |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | Includes changes in appetite, constipation, diarrhea, stomach pain/discomfort, changes in frequency of bowel movements, flatulence, heartburn, changes in stool color/consistency, vomiting, and gastrointestinal virus. |
|
| Infectious | Infections and infestations | Systematic Assessment | Includes common cold, fever, feeling flushed/warm, flu, and hand, foot and mouth. |
|
| Accidental Injury | Injury, poisoning and procedural complications | Systematic Assessment | Includes head injury, chin laceration, etc. |
|
| Muscular | Musculoskeletal and connective tissue disorders | Systematic Assessment | Includes muscle, joint and bone pain, head shaking, clumsiness, improved motor skills, and tics. |
|
| Headache | Nervous system disorders | Systematic Assessment |
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| Psychological | Psychiatric disorders | Systematic Assessment | Includes anxiety, aggression, increase in negative behaviors/emotions, confusion/slowed thinking, irritability, changes with speech, better memory, and understanding more. |
|
| Genital | Renal and urinary disorders | Systematic Assessment | Includes diurnal enuresis and improved toilet training. |
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| Nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Includes nasal/sinus congestion, runny nose, sore throat, strep throat, and tonsillectomy. |
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| Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Mouth | Musculoskeletal and connective tissue disorders | Systematic Assessment | Includes teething and jaw pain. |
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| Chest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Includes allergies, bronchitis, cold symptoms, coughing, and upper respiratory infection. |
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| Energy | Nervous system disorders | Systematic Assessment | Includes overly excited or energetic, calmness, and fatigue. |
|
| Sleep | Nervous system disorders | Systematic Assessment | Includes difficulty falling asleep, interrupted sleep, nightmares, drowsiness, and sleeping too much. |
|
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| IL-2 |
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| IFNγ |
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