- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06125782
Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Trial
November 5, 2023 updated by: Shawsun Tamanna Chowdhury, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shawsun Tamanna, MBBS
- Phone Number: 01733171110
- Email: shawsun.tamanna.alice@gmail.com
Study Contact Backup
- Name: Prof. Md. Sayedur Rahman, FCPS, M Phil.
- Phone Number: 01712205305
- Email: srkhasru@bsmmu.edu.bd
Study Locations
-
-
-
Dhaka, Bangladesh, 1000
- Recruiting
- BSMMU
-
Contact:
- Shawsun Tamanna, MBBS
- Phone Number: 01733171110
- Email: shawsun.tamanna.alice@gmail.com
-
Contact:
- Prof. Md.Sayedur Rahman, MBBS, M Phil
- Phone Number: 01712205305
- Email: srkhasru@bsmmu.edu.bd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Omega 3 fatty acid 1 gm softgel capsule- 1 for children at or below 25 kg and two for above 25 kg.
|
Placebo Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of baseline ASD symptoms at 8 weeks evaluated by Aberrant Behavior Checklist(parent rated)
Time Frame: baseline and 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in baseline plasma DHA level at 8 weeks; Change in baseline plasma EPA level at 8 weeks.
Time Frame: baseline and 8 weeks
|
Change in plasma DHA level from baseline to 8 weeks.
Higher DHA level indicates better outcome.
|
baseline and 8 weeks
|
Change in baseline plasma EPA level at 8 weeks;
Time Frame: baseline and 8 weeks.
|
Change in plasma EPA level from baseline to 8 weeks.
Higher EPA level indicates better outcome.
|
baseline and 8 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2023
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
January 1, 2024
Study Registration Dates
First Submitted
July 5, 2023
First Submitted That Met QC Criteria
November 5, 2023
First Posted (Estimated)
November 9, 2023
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 5, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSMMU/2023/5/965
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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