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Clinical Cohort Study of DHA in Neurodevelopmental Disorders

NCT05841927 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-18

No results posted yet for this study

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.

Conditions

  • Autism or Autistic Traits

Interventions

DIETARY_SUPPLEMENT

Docosahexaenoic acid supplement

Docosahexaenoic acid supplement

DIETARY_SUPPLEMENT

ASD placebo

ASD placebo

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Xiu Xu · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841927 on ClinicalTrials.gov