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Completed

NCT Number: NCT04312932

Fatty Acid Supplementation in Children With ASD (Study 2)

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

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

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

Primary outcomes

  1. 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

  1. Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite

    Time frame: Baseline to 90 days post randomization (End of Trial)

    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.

  2. Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems

    Time frame: Baseline to 90 days post randomization.

    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.

  3. Preschool Language Scales - 5 (PLS-5) Auditory Comprehension

    Time frame: Baseline to 90 days post randomization.

    Changes in Auditory Comprehension raw score. Higher scores represent better child comprehension of language. Raw scores range 0-65 for Auditory Comprehension.

  4. Childhood Autism Rating Scale (CARS2) (2nd ed.)

    Time frame: Baseline to 90 days post randomization.

    Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60.

  5. Autism Impact Measure - Total

    Time frame: Baseline to 90 days post randomization.

    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.

  6. Preschool Language Scales-5 Expressive Communication

    Time frame: Baseline (day 0) to end of trial (90 days)

    Changes in Expressive Communication raw score. Higher scores represent better child ability to communicate with others. Raw scores range 0-67.

  7. Preschool Language Scales-5 Total Language

    Time frame: Baseline (day 0) to end of trial (90 days)

    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.

  8. Autism Impact Measure - Restricted Behavior

    Time frame: Baseline to 90 days post randomization.

    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.

  9. Autism Impact Measure - Communication

    Time frame: Baseline to 90 days post randomization.

    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.

  10. Autism Impact Measure - Atypical Behavior

    Time frame: Baseline to 90 days post randomization.

    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.

  11. Autism Impact Measure - Social Reciprocity

    Time frame: Baseline to 90 days post randomization.

    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.

  12. Autism Impact Measure - Peer Interaction

    Time frame: Baseline to 90 days post randomization.

    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.

  13. Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication

    Time frame: Baseline to 90 days post randomization (End of Trial)

    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.

  14. Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization

    Time frame: Baseline to 90 days post randomization (End of Trial)

    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.

Sponsors and collaborators

Lead sponsor

Sarah Keim

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 18, 2020
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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