Clinical Cohort Study of DHA in Neurodevelopmental Disorders

NCT05841927 | Active Not Recruiting

• 1 other identifier: DHA_CHFU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Plasma level concentration of DHA (μg/ml)

  Detection and analysis of free fatty acid substances were performed using an Agilent 7890B gas chromatograph system coupled with a Agilent 5977B mass spectrometer.

  1, 3, 6 months

Secondary Outcomes (4)

• Change in developmental assessment

  1, 3, 6 months

• Change in autism severity assessed by DSM-5

  1, 3, 6 months

• Change in autism severity

  1, 3, 6 months

• Change in social adaptation ability

  1, 3, 6 months

Study Arms (2)

ASD active

EXPERIMENTAL

Dietary Supplement: Docosahexaenoic acid 200mg DHA once, twice a day

Dietary Supplement: Docosahexaenoic acid supplement

ASD placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo dietary intervention Vitamin D 400IU once, once a day

Dietary Supplement: ASD placebo

Interventions

Docosahexaenoic acid supplement DIETARY_SUPPLEMENT

Docosahexaenoic acid supplement

ASD active

ASD placebo DIETARY_SUPPLEMENT

ASD placebo

ASD placebo

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who were admitted to the Department of Child Care and Developmental Behavior of our hospital and diagnosed as ASD by developmental pediatricians according to the diagnostic criteria of DSM-5.
• Willing to participate in the study, consume the treatment and perform all measurements including developmental or cognitive testing, blood drawing, anthropometry and questionnaires etc.
• Informed consent signed by parent or caregiver.

You may not qualify if:

• Children with immune deficiency.
• Children with major organ malformations (congenital heart disease, nervous system tumors, obvious structural abnormalities of the nervous system, digestive tract malformations, etc.)
• Have a history of DHA allergy or obvious adverse reactions

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Xiu Xu

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 3, 2023
• Study Start: December 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)