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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2024-02-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omega-3 fatty acid

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.

Group Type ACTIVE_COMPARATOR

Omega 3 fatty acid

Intervention Type DRUG

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

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo of Omega-3 fatty acid softgel capsule

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Shawsun Tamanna Chowdhury

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

Responsibility Role PRINCIPAL_INVESTIGATOR