Autism spectrum disorders(ASD) are neurological disorders with different causes. Its assumed that children with ASD have abnormal neural connection, synaptic function and neurotransmitter imbalance. One study in Iran showed that ASD prevalence in school children is 1.9%. Although the cause of Autism is unknown, But environmental, Genetics and metabolic factors can be involved. It looks like that Genetics have a underlying role in ASD development. Other involved factors include Immunological, prenatal, neurological-anatomical and biochemical-psychological factors.
According to increasing prevalence of Autism and because there is not any study on Omega-3 supplementation in people with Autism, current study is performed to investigation of effects of Omega-3 supplementation in patients with Autism and determine the condition of behavioral indices.
General information
Acronym
The effect of Omega-3 on Autism spectrum disororders
IRCT registration information
IRCT registration number:IRCT2015122625699N1
Registration date:2016-01-24, 1394/11/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-24, 1394/11/04
Registrant information
Name
Saeid Doaei
Name of organization / entity
National Nutrition and Food Technology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 6643 6744
Email address
sdoaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-05-20, 1395/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega-3 supplementation on social, communication and behavior problems children with autism spectrum disorder
Public title
The effect of Omega-3 on Autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of Autism by psychologist; age between 5 to 15 years old; tend to cooperation; the severity of symptoms be moderate to severe.
Exclusion criteria: history of Omega3 supplementation; histiory of allergies to fish; people with diabetes and blood disorders; altered drug use in study duration; digestive symptoms in response to supplement intake.
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute
Street address
National Nutrition and Food Technology Research Institute
City
Tehran
Postal code
009821
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
054569
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorders
ICD-10 code
F84.0
ICD-10 code description
Primary outcomes
1
Description
Autism severity
Timepoint
Before intervention and 2 months after intervention
Method of measurement
GARZ Questionnaire
Secondary outcomes
1
Description
Social ineractions
Timepoint
Before and 2 months after intervention
Method of measurement
GARZ Questionnaire
2
Description
Communication
Timepoint
Before and 2 months after intervention
Method of measurement
GARZ Questionnaire
3
Description
Repeated behaviours
Timepoint
Before and 2 months after intervention
Method of measurement
GARZ Questionnaire
Intervention groups
1
Description
The case subjects receive 1 omega-3 capsula daily produced by Zahravi company, Iran.
Category
Treatment - Drugs
2
Description
The control subjects receive 1 placebo capsula daily produced by same company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Omide Ayandeh Autism center
Full name of responsible person
Street address
City
Rasht
2
Recruitment center
Name of recruitment center
Mansour school of exceptional children
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute