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

NCT06125782 | Completed Phase 2

• 1 other identifier: BSMMU/2023/5/965
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  baseline and 8 weeks

• Change in baseline plasma EPA level at 8 weeks;

  baseline and 8 weeks.

Study Arms (2)

Omega-3 fatty acid

ACTIVE COMPARATOR

One Omega-3 fatty acid softgel capsule 1 gm for children at or below 25 kg and two Omega-3 fatty acid softgel capsule above 25 kg. In this intervention arm having 32 participants, half will have plasma Omega 3 fatty acid level within reference value and rest half below reference value.

Drug: Omega 3 fatty acid

Placebo

PLACEBO COMPARATOR

Placebo softgels having almost same color and shape, one softgel for children at or above 25 kg and two softgels for children above 25 kg. In this placebo arm having 32 participants, half will have plasma Omega 3 fatty acid fatty acid level within reference value and rest half below reference value.

Drug: Placebo of Omega-3 fatty acid softgel capsule

Interventions

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.

Omega-3 fatty acid

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.

Placebo

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fulfills diagnosis of ASD by meeting DSM-5 diagnostic criteria. Written parental consent for participation. Age of children: 2-18 years. Sex: all.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children with Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Trial

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: November 9, 2023
• Study Start: September 19, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 5, 2024
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)