Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sarah Keim
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 6 Years (Child)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
Long chain polyunsaturated fatty acid (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
Intervention: LCPUFA Oil Supplement (Drug)
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
Intervention: Canola Oil Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite
Time Frame: 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 Outcomes
- Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite(Baseline to 90 days post randomization (End of Trial))
- Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems(Baseline to 90 days post randomization.)
- Preschool Language Scales - 5 (PLS-5) Auditory Comprehension(Baseline to 90 days post randomization.)
- Childhood Autism Rating Scale (CARS2) (2nd ed.)(Baseline to 90 days post randomization.)
- Autism Impact Measure - Total(Baseline to 90 days post randomization.)
- Preschool Language Scales-5 Expressive Communication(Baseline (day 0) to end of trial (90 days))
- Preschool Language Scales-5 Total Language(Baseline (day 0) to end of trial (90 days))
- Autism Impact Measure - Restricted Behavior(Baseline to 90 days post randomization.)
- Autism Impact Measure - Communication(Baseline to 90 days post randomization.)
- Autism Impact Measure - Atypical Behavior(Baseline to 90 days post randomization.)
- Autism Impact Measure - Social Reciprocity(Baseline to 90 days post randomization.)
- Autism Impact Measure - Peer Interaction(Baseline to 90 days post randomization.)
- Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication(Baseline to 90 days post randomization (End of Trial))
- Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization(Baseline to 90 days post randomization (End of Trial))
Investigators
Sarah Keim
Principal Investigator
Nationwide Children's Hospital