Clinical trial NCT00786799: Omega-3 Fatty Acids for Autism Treatment
Official title: A Randomized, Double-Blind, Placebo-Controlled 12-week Study to Investigate the Effect of Omega-3 Fatty Acids on Hyperactivity in Childhood Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Autism Speaks
First posted: 2008-11-06
Enrollment: 27
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Change in Percentage of Serum Omega-3 Fatty Acids
timeFrame: Baseline and 1 year
measure: Change in Serum TNFα (Cytokine) Level
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UC San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stephen Bent, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC San Francisco
name: Robert L Hendren, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lunsky Y, P Hastings R, Weiss JA, M Palucka A, Hutton S, White K. Comparative Effects of Mindfulness and Support and Information Group Interventions for Parents of Adults with Autism Spectrum Disorder and Other Developmental Disabilities. J Autism Dev Disord. 2017 Jun;47(6):1769-1779. doi: 10.1007/s10803-017-3099-z.
citation: Bent S, Bertoglio K, Ashwood P, Bostrom A, Hendren RL. A pilot randomized controlled trial of omega-3 fatty acids for autism spectrum disorder. J Autism Dev Disord. 2011 May;41(5):545-54. doi: 10.1007/s10803-010-1078-8.