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Omega-3 Fatty Acids for Autism Treatment

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ClinicalTrials.gov Identifier: NCT00786799
Recruitment Status : Completed
First Posted : November 6, 2008
Results First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autism
Intervention Dietary Supplement: Omega-3 Fatty Acids
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description 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). 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.
Period Title: Overall Study
Started 14 13
Completed 13 12
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Omega-3 Fatty Acids Placebo Total
Hide Arm/Group Description 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). 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. Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
<=18 years
14
 100.0%
13
 100.0%
27
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 27 participants
5.85  (1.83) 5.82  (1.42) 5.83  (1.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
1
   7.1%
2
  15.4%
3
  11.1%
Male
13
  92.9%
11
  84.6%
24
  88.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 13 participants 27 participants
14 13 27
1.Primary Outcome
Title 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)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Omega-3 Placebo Comparison Between Omega-3 and Placebo Groups
Hide Arm/Group Description:
Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Omega-3 Group Only
Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Placebo Group Only
Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score between Omega-3 and Placebo groups (p-value given in statistical analysis section)
Overall Number of Participants Analyzed 13 12 25
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.7  (4.8) 0.3  (7.2) 2.3  (6.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comparison Between Omega-3 and Placebo Groups
Comments The null hypothesis is that the mean change in Aberrant Behavior Checklist Hyperactivity subscale (ABC-H) score is the same for both groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.3
Parameter Dispersion
Type: Standard Deviation
Value: 6.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Percentage of Serum Omega-3 Fatty Acids
Hide Description Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Omega-3 Group: Change in Levels of Omega 3 Fatty Acids Placebo Group: Change in Levels of Omega 3 Fatty Acids
Hide Arm/Group Description:
Change in percentage of serum levels of Omega-3 fatty acids in the active Omega-3 group (100% * ((One Year - Baseline)/Baseline)
Change in percentage of serum levels of Omega-3 fatty acids in the placebo group (100% * ((One Year - Baseline)/Baseline).
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: Percent change of levels of fatty acid
2.54  (2.8) -0.10  (0.3)
3.Secondary Outcome
Title Change in Serum TNFα (Cytokine) Level
Hide Description [Not Specified]
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Omega-3 Group: Change in TNFα Placebo Group: Change in TNFα
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: pg/ml
1.3  (2.5) -0.9  (2.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description 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). 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.
All-Cause Mortality
Omega-3 Fatty Acids Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Omega-3 Fatty Acids Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omega-3 Fatty Acids Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/14 (35.71%)      4/13 (30.77%)    
Blood and lymphatic system disorders     
Nose Bleed   1/14 (7.14%)  1 0/13 (0.00%)  0
Gastrointestinal disorders     
GI Symptoms   1/14 (7.14%)  1 0/13 (0.00%)  0
Nervous system disorders     
Increased Hyperactivity *  0/14 (0.00%)  0 3/13 (23.08%)  3
Increased Self-Stimulating Behavior *  0/14 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection   1/14 (7.14%)  1 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash   2/14 (14.29%)  2 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
  1. Small sample size which results in a limited power to detect small to moderate treatment effects.
  2. Relatively mild level of hyperactivity in both groups.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert L. Hendren, D.O.
Organization: University of California, San Francisco
Phone: 415-476-7198
EMail: robert.hendren@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00786799    
Other Study ID Numbers: 200816175-1
First Submitted: November 5, 2008
First Posted: November 6, 2008
Results First Submitted: September 14, 2011
Results First Posted: August 31, 2012
Last Update Posted: August 31, 2012