Omega-3 fatty acid effects on children with autism
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 testing if giving Omega-3 fatty acids to children with autism can improve their behavior compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06125782 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of Omega-3 fatty acid supplementation on the neurobehavioral status of children diagnosed with Autism Spectrum Disorder (ASD). Conducted as a randomized, double-blind, placebo-controlled trial, it will involve 64 participants aged 2 to 18 years who meet the DSM-5 criteria for ASD. Participants will be divided into two groups based on their Omega-3 levels and will receive either Omega-3 supplements or a placebo for 8 weeks. The study will assess changes in behavior using a validated checklist and measure Omega-3 levels in plasma.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 18 years diagnosed with Autism Spectrum Disorder.
Not a fit: Patients currently taking Omega-3 fatty acids or those with psychotic or mood disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary intervention to improve neurobehavioral symptoms in children with autism.
How similar studies have performed: While some studies have explored Omega-3 supplementation in various conditions, this specific approach in ASD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dhaka
- Bsmmu — Dhaka, Bangladesh (Recruiting)
Study contacts
- Study coordinator: Shawsun Tamanna, MBBS
- Email: shawsun.tamanna.alice@gmail.com
- Phone: 01733171110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.