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Fatty Acid Supplementation in Children With ASD (Study 2)

NCT ID: NCT04312932

Last Updated: 2025-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-04-11

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

LCPUFA Oil Supplement

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Canola Oil Placebo

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Sarah Keim

OTHER

Sponsor Role lead

Responsible Party

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Sarah Keim

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sarah Keim, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Lynette Rogers, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R33AT009632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB17-00517-2

Identifier Type: -

Identifier Source: org_study_id