ClinicalTrials.gov
ClinicalTrials.gov Menu

Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00467818
Recruitment Status : Unknown
Verified November 2010 by Rutgers, The State University of New Jersey.
Recruitment status was:  Recruiting
First Posted : May 1, 2007
Last Update Posted : November 24, 2010
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
Rutgers, The State University of New Jersey

April 27, 2007
May 1, 2007
November 24, 2010
January 2007
September 2010   (Final data collection date for primary outcome measure)
  • Clinical Global Impression-Improvement (CGI) [ Time Frame: Administered biweekly ]
  • Aberrant Behavior Checklist (ABC) [ Time Frame: Administered every 4 weeks ]
  • Vineland Adaptive Behavior Scale [ Time Frame: Administered during the baseline visit and on week 12 ( termination) ]
  • Clinical Global Impression-Improvement (CGI), administered biweekly
  • Aberrant Behavior Checklist (ABC), administered every 4 weeks
  • Vineland Adaptive Behavior Scale, administered during the pre-study and on week 12
Complete list of historical versions of study NCT00467818 on ClinicalTrials.gov Archive Site
  • Overt Aggression Scale-Modified [ Time Frame: Administered every 4 weeks ]
  • Parental Stress Index [ Time Frame: Administered during the baseline visit and on week 12 ( termination) ]
  • Overt Aggression Scale-Modified, administered every 4 weeks
  • Parental Stress Index, administered during the baseline visit and on week 12
Not Provided
Not Provided
 
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders

Published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in CGI, YMRS, and HAM-D scores. The following are the hypotheses:

  • Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism.
  • Omega 3 fatty acids will be superior to placebo in improving aggression and irritability associated with autism.
  • Omega 3 fatty acids will be superior to placebo in improving functional ability.
This study is an innovative treatment approach to autism. It adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. It will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. Finally, it will attempt to identify which specific subgroups of subjects will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects' quality of life. The data generated by this study is intended to support the rationale for a full scale, large multi-site clinical trial.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism
  • Dietary Supplement: Omega 3 fatty acids
    The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.
    Other Name: Docasahexanoic acid
  • Other: Placebo
    Smae dosage as that of omega 3 fatty acids
  • Experimental: Omega 3 fatty Acids
    Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.
    Intervention: Dietary Supplement: Omega 3 fatty acids
  • Placebo Comparator: Placebo
    The placebo will be dispensed to subjects in the control group
    Intervention: Other: Placebo
Amminger GP, Berger GE, Schafer MR, Klier C, Friedrich MH, Feucht M. Omega-3 Fatty Acids Supplementation in Children with Autism. Biol Psychiatry. 2006 Aug 22 Harel Z, Gascon G, Riggs S, Vaz R, Brown W, Exil G. Supplementation with omega-3 polyunsaturated fatty acids in the management of recurrent migraines in adolescents. J Adolesc Health. 2002 Aug;31(2):154-61. Itomura M, Hamazaki K, Sawazaki S, Kobayashi M, Terasawa K, Watanabe S, Hamazaki T. The effect of fish oil on physical aggression in schoolchildren. J Nutr Biochem. 2005 Mar;16(3):163-71. Mitchell EA, Aman MG, Turbott SH, Manku M. Clinical characteristics and serum essential fatty acid levels in hyperactive children. Clin Pediatr 1987; 26:406-11. Nemets H, Nemets B, Apter A, Bracha Z, Belmaker RH Omega-3 treatment of childhood depression: Am J Psychiatry. 2006 Jun;163(6):1098-100. Richardson AJ, Montgomery P. The Oxford-Durham study. Pediatrics. 2005 May;115(5):1360-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Child/Teen has autism.
  • He/She is between five and seventeen years of age.
  • He/She is not in the hospital.
  • He/She has a parent or legal guardian who is willing and able to sign the informed consent.

Exclusion Criteria:

  • Child/Teen has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
  • He/She has caused visible harm to him/herself or is at risk for suicide.
  • He/She has an active seizure disorder or epilepsy (seizures within the past year).
  • He/She has an unstable medical illness, including heart disease.
  • He/She has experienced brain injury.
  • He/She has a history of diabetes.
  • He/She has a history of prior treatment with Omega 3 Fatty Acids.
  • He/She lives in a far away area and/or does not have regular access to transportation to the clinical facility.
  • A pregnant female or unwilling to use acceptable contraception if sexually active.
Sexes Eligible for Study: All
5 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00467818
0220060238
Yes
Not Provided
Not Provided
Dr.Sherie Novotny, UMDNJ-RWJMS
University of Medicine and Dentistry of New Jersey
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Sherie L. Novotny, MD Division of Child and Adolescent Psychiatry at the University of Medicine and Dentistry of New Jersey
Rutgers, The State University of New Jersey
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP