Autism
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOmega-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
Sponsors
Autism Speaks
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Serum Omega-3 Fatty Acids | Baseline and 1 year | Change in percentage calculated as (100% \* ((One Year - Baseline)/Baseline) |
| Change in Serum TNFα (Cytokine) Level | Baseline and 1 year | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omega-3 Fatty Acids Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA). | 14 |
| Placebo Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to non-omega-3 fatty acids. | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Omega-3 Fatty Acids | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 5.82 years STANDARD_DEVIATION 1.42 | 5.85 years STANDARD_DEVIATION 1.83 | 5.83 years STANDARD_DEVIATION 1.67 |
| Region of Enrollment United States | 13 participants | 14 participants | 27 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 14 | 4 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
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)
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.
Time frame: Baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Omega-3 | 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) | 2.7 scores on a scale | Standard Deviation 4.8 |
| Placebo | 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) | 0.3 scores on a scale | Standard Deviation 7.2 |
| Comparison Between Omega-3 and Placebo Groups | 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) | 2.3 scores on a scale | Standard Deviation 6.1 |
Comparison: The null hypothesis is that the mean change in Aberrant Behavior Checklist Hyperactivity subscale (ABC-H) score is the same for both groups.p-value: 0.4t-test, 2 sided
Secondary
Change in Percentage of Serum Omega-3 Fatty Acids
Change in percentage calculated as (100% \* ((One Year - Baseline)/Baseline)
Time frame: Baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Omega-3 | Change in Percentage of Serum Omega-3 Fatty Acids | 2.54 Percent change of levels of fatty acid | Standard Deviation 2.8 |
| Placebo | Change in Percentage of Serum Omega-3 Fatty Acids | -0.10 Percent change of levels of fatty acid | Standard Deviation 0.3 |
Secondary
Change in Serum TNFα (Cytokine) Level
Time frame: Baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Omega-3 | Change in Serum TNFα (Cytokine) Level | 1.3 pg/ml | Standard Deviation 2.5 |
| Placebo | Change in Serum TNFα (Cytokine) Level | -0.9 pg/ml | Standard Deviation 2.1 |