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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: Omega 3 fatty acid; Drug: Placebo of Omega-3 fatty acid softgel capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06125782

BSMMU/2023/5/965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

Omega-3 fatty acid

Active Comparator group

Description:

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.

Treatment:

Drug: Omega 3 fatty acid

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo of Omega-3 fatty acid softgel capsule