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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125782
• Other study ID #: BSMMU/2023/5/965
• Status: Recruiting
• Phase: Phase 2
• Start date: September 19, 2023
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: Shawsun Tamanna, MBBS
• Phone: 01733171110
• Email: shawsun.tamanna.alice[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Bangladesh	BSMMU	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

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.