Fatty Acid Supplementation in Children With ASD (Study 2)

Autism Spectrum Disorder Clinical Trial

— Omega Heroes  

Official title:

Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04312932
• Other study ID #: IRB17-00517-2
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: December 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: January 31, 2024
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

• 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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Drug:
• LCPUFA Oil Supplement
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 Supplement:
• 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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Sarah Keim	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite	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.	Baseline to 90 days post randomization.
Secondary	Vineland Adaptive Behavior Scales 2nd ed. (modified timeframe of 90 days)	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.	Baseline to 90 days post randomization.
Secondary	Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems	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.	Baseline to 90 days post randomization.
Secondary	Preschool Language Scales - 5 (PLS-5)	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.	Baseline to 90 days post randomization.
Secondary	Childhood Autism Rating Scale (CARS2) (2nd ed.)	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)	Baseline to 90 days post randomization.
Secondary	Autism Impact Measure	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.	Baseline to 90 days post randomization.