Fatty Acid Supplementation in Children With ASD (Study 2)
- Conditions
- Autism Spectrum Disorder
- Interventions
- Drug: LCPUFA Oil SupplementDietary Supplement: Canola Oil Placebo
- Registration Number
- NCT04312932
- Lead Sponsor
- Sarah Keim
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- Age 2-6 years old
- ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
- English is primary language
- Fatty acid supplementation in the past 6 months
- Consumes fatty fish more than 3 times per week
- Still breastfeeding or formula feeding
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement LCPUFA Oil Supplement 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 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
- Primary Outcome Measures
Name Time Method Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite Baseline to 90 days post randomization. Change in PDDBI Autism Composite t-score. Autism Composite t-scores range from 0-100 (mean=50; SD=10). T scores ranging 40-60 are characteristic of most cases of autism. Higher scores indicate greater severity. T scores for the Social Approach Behaviors and Expressive Language domains are summed and subtracted from the sum of the T scores for the Sensory/Perceptual Approach Behaviors, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains to obtain the Autism Composite t-score.
- Secondary Outcome Measures
Name Time Method Childhood Autism Rating Scale (CARS2) (2nd ed.) Baseline to 90 days post randomization. Changes in Continuous Score. T-scores range 45-54 indicate average level of autism-related symptoms; T-scores \>70 indicate extreme level of autism-related symptoms (higher scores indicate greater symptoms)
Preschool Language Scales - 5 (PLS-5) Baseline to 90 days post randomization. Changes in Auditory Comprehension, Expressive Communication, and Total Language Scale standard scores. Standard score range 50-150 (mean=100; SD=15). Higher scores represent better child comprehension of language and better ability to communicate with others.
Vineland Adaptive Behavior Scales 2nd ed. (modified timeframe of 90 days) Baseline to 90 days post randomization. Change in standard adaptive composite score, and communication and socialization subdomain scores. A standard score of \<86 is an indication of low adaptive level (characteristic of children with autism)(lower scores indicate lower adaptive level). Mean=100, SD=15, range 20-160.
Autism Impact Measure Baseline to 90 days post randomization. The Autism Impact Measure is a newly developed instrument for measuring change in ASD related behaviors. https://pubmed.ncbi.nlm.nih.gov/30968318/ Changes in ASD core symptoms based on the following subscales: Repetitive Behavior, Communication; Atypical Behavior; Social Reciprocity; Peer Interaction; Frequency; Impact. (established norms not yet available) Higher scores represent worse severity of ASD symptoms.
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems Baseline to 90 days post randomization. Change in PDDBI Aggressiveness Problems t-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 t-scores range from 0-100 (mean 50; SD=10); higher scores are indicative of more aggressiveness.
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States