Omega-3 Fatty Acids for Autism Treatment

This study has been completed.
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00786799
First received: November 5, 2008
Last updated: July 31, 2012
Last verified: July 2012
Results First Received: September 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Autism
Intervention: Dietary Supplement: Omega-3 Fatty Acids

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).
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.

Participant Flow:   Overall Study
    Omega-3 Fatty Acids     Placebo  
STARTED     14     13  
COMPLETED     13     12  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).
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.
Total Total of all reporting groups

Baseline Measures
    Omega-3 Fatty Acids     Placebo     Total  
Number of Participants  
[units: participants]
  14     13     27  
Age  
[units: participants]
     
<=18 years     14     13     27  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  5.85  ± 1.83     5.82  ± 1.42     5.83  ± 1.67  
Gender  
[units: participants]
     
Female     1     2     3  
Male     13     11     24  
Region of Enrollment  
[units: participants]
     
United States     14     13     27  



  Outcome Measures
  Show All Outcome Measures

1.  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)   [ Time Frame: Baseline and 1 year ]

2.  Secondary:   Change in Percentage of Serum Omega-3 Fatty Acids   [ Time Frame: Baseline and 1 year ]

3.  Secondary:   Change in Serum TNFα (Cytokine) Level   [ Time Frame: Baseline and 1 year ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  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.
 


Results Point of Contact:  
Name/Title: Robert L. Hendren, D.O.
Organization: University of California, San Francisco
phone: 415-476-7198
e-mail: robert.hendren@ucsf.edu


No publications provided by University of California, San Francisco

Publications automatically indexed to this study:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00786799     History of Changes
Other Study ID Numbers: 200816175-1
Study First Received: November 5, 2008
Results First Received: September 14, 2011
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board