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NCT Number: NCT06125782

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BSMMU

Dhaka, 1000, Bangladesh

About this study

Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder of children with lifelong impacts. WHO estimates the international prevalence of ASD in 2022 at 1 in 100 children. Till date, no pharmacological treatment has been proven effective for ASD. This proposed study is an effort to explore whether Omega-3 fatty acid supplementation produces improvement in neurobehavioral symptoms of ASD. This study will be a randomized, double-blind, placebo-controlled trial.A total of sixty four (64) ASD patients attended in the outpatient department of IPNA, BSMMU will be selected for the study according to inclusion and exclusion criteria. Diagnosis of ASD will be made by DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition). After completion of necessary formalities including informed consent of the patients, each participant will be assessed by translated and validated Bangla version of Aberrant Behaviour Checklist (ABC-parents rated). Omega-3 fatty acid ( Docosahexaenoic acid, DHA and Eicosapentaenoic acid, EPA) level in plasma will be measured in HPLC. 32 patients having DHA and EPA within reference value and 32 patients below the reference value will be selected. Then participants of each group will randomly be assigned into two groups: Intervention group and Control group. The intervention group patients will receive Omega-3 fatty acid 1 gm softgel once daily for 8 weeks at or below 25 kg and 1 gm softgel twice daily for 8 weeks above 25 kg making a total dose of 2gm/day. On the other hand, patients in control group will receive 1 placebo softgel of 1 gm once daily for 8 weeks at or below 25 kg and twice daily above 25 kg. After 8 weeks of therapy each participant will be assessed once again by Bangla version of ABC and plasma level of DHA and EPA will be measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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.

Treatment and study plan

Omega 3 fatty acid

Drug

Omega 3 fatty acid 1 gm softgel capsule- 1 for children at or below 25 kg and two for above 25 kg.

Placebo of Omega-3 fatty acid softgel capsule

Drug

Placebo of Omega-3 fatty acid softgel capsule- colour and shape almost similar to the original drug- 1 for children at or below 25 kg and 2 for above 25 kg.

Primary outcomes

  1. Change of baseline ASD symptoms at 8 weeks evaluated by Aberrant Behavior Checklist(parent rated)

    Time frame: baseline and 8 weeks

    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.

Secondary outcomes

  1. Change in baseline plasma DHA level at 8 weeks; Change in baseline plasma EPA level at 8 weeks.

    Time frame: baseline and 8 weeks

    Change in plasma DHA level from baseline to 8 weeks. Higher DHA level indicates better outcome.

  2. Change in baseline plasma EPA level at 8 weeks;

    Time frame: baseline and 8 weeks.

    Change in plasma EPA level from baseline to 8 weeks. Higher EPA level indicates better outcome.

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children With Autism Spectrum Disorder: A Randomized, Double- Blind, Placebo Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2023
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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