Skip to main content
OpenTrials
Completed

NCT Number: NCT00786799

Omega-3 Fatty Acids for Autism Treatment

Omega-3 fatty acids are among the most commonly used CAM (Complementary Alternative Medical) therapies, and have been reported to be currently used by 28.7% of children with autism. Two published case series noted that families reported large improvements in the core feature of autism when children were given omega-3 fatty acids. Low levels of omega-3 fatty acids have been noted in children with autism, which suggests normalizing the omega-3 fatty acid levels could produce improvements in the symptoms seen in many children with autism.

This study is a 12-week randomized, double blind, placebo-controlled clinical trial for 24 male and female children aged 3 to 8 years with autism. Patients who are currently using omega-3 would need to discontinue omega-3 fatty acids for 8 weeks before they are able to participate in the study. All study participants who meet all inclusion and no exclusion criteria at the initial screening visit and sign the consent form will then complete baseline assessments of the outcome measures (validated instruments of hyperactivity, communication, social interaction, and behavior) and be randomly assigned to 12 weeks of omega-3 fatty acids at a dose of 1 gm per day or an identical placebo. The child's behavior will be measured and evaluated at the MIND Institute at the beginning of the study and at study closing. All study families will come in for a follow-up visit at weeks 4 and 8 to assess medication compliance and side effects to study medication.

After 12 weeks of treatment, all outcome measures including laboratory tests and side effect profiles will be repeated. All patients who complete the study will receive a 12-week supply of omega-3. This would also provide patients who were on placebo with active medication. No follow-up visits are needed once the patient finishes the double-blind portion of the study.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UC San Francisco

San Francisco, California, 94143, United States

About this study

Clinical measures will be used to assess diagnosis and efficacy. All clinical assessments will take place at the M.I.N.D. Institute. Baseline and termination measures will include the Aberrant Behavior Checklist (ABC), Peabody Picture Vocabulary Test (PPVT-III), Expressive Vocabulary Test (EVT), Social Responsiveness Scale (SRS), Behavior Assessment System for Children (BASC), and Clinical Global Impression Improvement (CGI-I). The, the Wechsler Preschool Primary Scale of Intelligence - Revised (WPPSI-R), the Wechsler Intelligence Scale for Children (WISC) or the Stanford-Binet will be administered to measure IQ.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of autism as defined by DSM-IV TR and scores above the cutoff on the Autism Diagnostic Observation Scale (ADOS) and the Social Communication Questionnaire (SCQ)
  • Age three to eight years
  • Non-verbal IQ of 50 or above
  • Children on a stable medical regimen for the past 2 months and no plans to change medical therapy for the study period

Exclusion criteria

  • Individuals with allergy or hypersensitivity to fish or nuts
  • Diabetes
  • Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent surgery
  • Clinical evidence of seizure disorder
  • Cancer
  • Fragile X or other known genetic cause of autism
  • Perinatal brain injury
  • Evidence for malnutrition seen in abnormal albumin level
  • Other serious medical illness
  • Current use of omega-3 fatty acids

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

Omega-3's are administered in the form of an orange pudding made by Coromega

1 mg of omega-3 fatty acid 2 times per day

Other names: Omega-3, N-3 Fatty Acid

Primary outcomes

  1. Group-specific and Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score (Active Omega-3 Group Only, Placebo Group Only and Comparison Between Groups)

    Time frame: Baseline and 1 year

    Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from "no problem" to "major problem"). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement.

Secondary outcomes

  1. Change in Percentage of Serum Omega-3 Fatty Acids

    Time frame: Baseline and 1 year

    Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)

  2. Change in Serum TNFα (Cytokine) Level

    Time frame: Baseline and 1 year

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Autism Speaks

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled 12-week Study to Investigate the Effect of Omega-3 Fatty Acids on Hyperactivity in Childhood Autism

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 6, 2008
Registry last updated
Aug 31, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.