Clinical trial
Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children With Autism Spectrum Disorder: A Randomized, Double- Blind, Placebo Controlled Trial
Name
BSMMU/2023/5/965
Description
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.
Trial arms
Trial start
2023-09-19
Estimated PCD
2024-01-01
Trial end
2024-01-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Omega-3 fatty acid
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.
Arms:
Placebo
Size
64
Primary endpoint
Change of baseline ASD symptoms at 8 weeks evaluated by Aberrant Behavior Checklist(parent rated)
baseline and 8 weeks
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ESTIMATED'}}
Updated at
2023-11-09
1 organization
2 products
1 indication
Organization
Bangabandhu Sheikh Mujib Medical UniversityProduct
Omega 3 fatty acidIndication
Autism Spectrum DisorderProduct
Omega-3 fatty acid