Autism Spectrum Disorder Clinical Trial
Official title:
Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children With Autism Spectrum Disorder: A Randomized, Double- Blind, Placebo Controlled Trial
This study is conducted to assess whether Omega-3 fatty acid improves neurobehavioral staus of children with Autism Spectrum Disorder and whether there is any correlation of this improvement with reference range of Omega-3 fatty acid.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | Inclusion Criteria: Fulfills diagnosis of ASD by meeting DSM-5 diagnostic criteria. Written parental consent for participation. Age of children: 2-18 years. Sex: all. - Exclusion Criteria: Those taking Omega-3 fatty acid or fish oil at present. Known allergy to fish or fish oil. Diagnosed with a psychotic disorder (e.g. Schizophrenia) or mood disorder, including depression or bipolar disorder. |
Country | Name | City | State |
---|---|---|---|
Bangladesh | BSMMU | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of baseline ASD symptoms at 8 weeks evaluated by Aberrant Behavior Checklist(parent rated) | Change of ASD symptoms from baseline to 8 weeks measured by Aberrant Behavior Checklist (ABC)- community. ABC is a 58 item questionnaire designed to measure the symptoms of Autism spectrum disorder. It has 5 subscales- irritability, social withdrawal, stereotypic behavior, hyperactivity/ non-compliance, Inappropriate speech consisting of 15, 16, 7, 16 and 4 items respectively. The lower scores indicate better outcome. | baseline and 8 weeks | |
Secondary | Change in baseline plasma DHA level at 8 weeks; Change in baseline plasma EPA level at 8 weeks. | Change in plasma DHA level from baseline to 8 weeks. Higher DHA level indicates better outcome. | baseline and 8 weeks | |
Secondary | Change in baseline plasma EPA level at 8 weeks; | Change in plasma EPA level from baseline to 8 weeks. Higher EPA level indicates better outcome. | baseline and 8 weeks. |
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