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ACTIVE NOT RECRUITING
NCT05841927
NA

Clinical Cohort Study of DHA in Neurodevelopmental Disorders

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

Summary

Neurodevelopmental disorders are a group of developmental disorders, including autism spectrum disorders (ASDs), attention deficit hyperactivity disorder (ADHD) and others, that begin at a developmental stage and severely affect the growth and development of the brain. Autism spectrum disorder (ASD) encompasses a group of neurodevelopmental syndromes characterized by deficits in social interaction and communication as well as repetitive behaviors and restricted interests. There is strong evidence for the involvement of inherited genetic factors in ASD (accounting for at least 80% of the variation in disease risk). There is strong evidence for the involvement of inherited genetic factors in ASD (accounting for at least 80% of the variation in disease risk). According to a meta-analysis, monogenic mutations in SHANK3, which encodes the major postsynaptic density (PSD) scaffolding protein at excitatory glutamatergic synapses, are found in approximately 0.69% of ASD cases and up to 2.12% of all moderate to profound intellectual disability cases. De novo mutations, interstitial deletions, and terminal deletions have been identified in ASD. Recent studies have shown that children with ASD have significantly lower levels of docosahexaenoic acid (DHA) than those without. Studies have shown that higher DHA intake reduces the risk of schizophrenia, bipolar disorder, depression, anxiety disorder, and conduct disorders. After DHA treatment, most children with ASD showed clinical and biochemical improvements, with increased DHA levels as measured by blood analysis and significant improvements in social scale scores in the supplement group. Moreover, increasing DHA levels in children with ADHD through dietary supplements can improve behavior, attention, literacy, cognitive problems, and working memory function. Therefore, for neurodevelopmental disorders, high DHA intake may be an important component of disease prevention.

Key Details

Gender

All

Age Range

2 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-12-01

Completion Date

2025-12-01

Last Updated

2025-02-18

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Docosahexaenoic acid supplement

Docosahexaenoic acid supplement

DIETARY_SUPPLEMENT

ASD placebo

ASD placebo

Locations (1)

Children's Hospital of Fudan University

Shanghai, China