- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00786799
Omega-3 Fatty Acids for Autism Treatment
A Randomized, Double-Blind, Placebo-Controlled 12-week Study to Investigate the Effect of Omega-3 Fatty Acids on Hyperactivity in Childhood Autism
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- UC San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
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 Fatty Acids in orange pudding form 1 packet two times per day
Other Names:
|
Active Comparator: 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
Other Names:
Omega-3 Fatty Acids in orange pudding form 1 packet two times per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline and 1 year
|
Change in Serum TNFα (Cytokine) Level
Time Frame: Baseline and 1 year
|
Baseline and 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephen Bent, MD, University of California, San Francisco
- Principal Investigator: Robert L Hendren, DO, UC San Francisco
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200816175-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism
-
EarliTec Diagnostics, IncMarcus Autism CenterRecruitingAutism Spectrum Disorder | Developmental Delay | Autism | Autism, Early Infantile | Autism, InfantileUnited States
-
IRIS Media IncCompletedAutism DisorderUnited States
-
University of California, San FranciscoWithdrawn
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
Forest LaboratoriesMerz Pharmaceuticals GmbHCompletedAutism | Pediatric AutismUnited States
-
University of Medicine and Dentistry of New JerseyNational Alliance for Autism ResearchCompleted
-
The Hong Kong Polytechnic UniversityRecruitingAutism Spectrum Disorder | High-functioning AutismHong Kong
-
Emory UniversityNational Institute of Mental Health (NIMH)Terminated
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Florida State University; Autism...CompletedAutism Spectrum DisordersUnited States
-
University Hospital, MontpellierCaisse Nationale de Solidarité pour l'AutonomieActive, not recruitingAutism Spectrum DisordersFrance
Clinical Trials on Omega-3 Fatty Acids
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBreast Neoplasms | ArthralgiaUnited States
-
S.LAB (SOLOWAYS)Center of New Medical Technologies; Triangel ScientificCompletedLDL Hyperlipoproteinemia | Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia | Triglyceride Storage Type I or II DiseaseRussian Federation
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National... and other collaboratorsCompleted
-
Wen-Chih WuWithdrawnSteatosis | Right Ventricular Failure | Pulmonary; HypertensionUnited States
-
Pennington Biomedical Research CenterCompleted
-
Evandro Chagas Institute of Clinical ResearchAndrea Silvestre de Sousa, MD PhD; Pedro Emmanuel Alvarenga Americano do Brasil... and other collaboratorsCompletedChagas CardiomyopathyBrazil
-
Retina Foundation of the SouthwestDSM Nutritional Products, Inc.CompletedInfant DevelopmentUnited States
-
Hugo W. Moser Research Institute at Kennedy Krieger...University of California, San FranciscoCompletedAutism Spectrum Disorders | HyperactivityUnited States
-
Centre for Chronic Disease Control, IndiaCompleted
-
Shanghai Mental Health CenterHarbin Medical University; Qingdao Mental Health CenterRecruitingBipolar Disorder | Major Depressive Disorder | Omega-3 Fatty AcidsChina