Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2008-08-31
2009-09-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Omega-3 Fatty Acids
Omega-3 Fatty Acids
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
Placebo
Omega-3 Fatty Acids
Omega-3 Fatty Acids in orange pudding form
1 packet two times per day
Interventions
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Omega-3 Fatty Acids
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
Omega-3 Fatty Acids
Omega-3 Fatty Acids in orange pudding form
1 packet two times per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
8 Years
ALL
No
Sponsors
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Autism Speaks
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Stephen Bent, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Robert L Hendren, DO
Role: PRINCIPAL_INVESTIGATOR
UC San Francisco
Locations
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UC San Francisco
San Francisco, California, United States
Countries
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References
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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.
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.
Other Identifiers
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200816175-1
Identifier Type: -
Identifier Source: org_study_id