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

NCT06125782 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-07-09

No results posted yet for this study

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

Interventions

DRUG

Omega 3 fatty acid

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

DRUG

Placebo of Omega-3 fatty acid softgel capsule

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.

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2024-01-30
Completion
2024-02-05

Countries

  • Bangladesh

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06125782 on ClinicalTrials.gov