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NCT Number: NCT05841927

Clinical Cohort Study of DHA in Neurodevelopmental Disorders

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, China

About this study

For neurodevelopmental disorders, high DHA intake may be an important component of disease prevention. DHA is a safe dietary supplement and is safe for children. Clinical diagnosis and treatments of SHANK, ASD and ADHD were carried out for a long time and a solid foundation for clinical cohort research has accumulated. This study aims to observe the effectiveness of DHA supplementation as an adjuvant therapy for ASD by establishing randomized cohort cases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Docosahexaenoic acid supplement

Dietary Supplement

Docosahexaenoic acid supplement

ASD placebo

Dietary Supplement

ASD placebo

Primary outcomes

  1. Plasma level concentration of DHA (μg/ml)

    Time frame: 1, 3, 6 months

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

Secondary outcomes

  1. Change in developmental assessment

    Time frame: 1, 3, 6 months

    Griffiths Mental Development Scales (Griffiths) were conducted by licensed and certified clinicians to assess developmental and cognitive level which is applicable to the children with mental age (not physical age) from 0 to 8.

    The developmental quotient in each zone represents the developmental status of the child. The higher the developmental quotient, the better the child's development.

  2. Change in autism severity assessed by DSM-5

    Time frame: 1, 3, 6 months

    ASD severity was based on the DSM-5 administrated by certified clinicians. The higher the score, the more severe the symptoms

  3. Change in autism severity

    Time frame: 1, 3, 6 months

    ASD severity was based on the ADOS-2 administrated by certified clinicians. The higher the score, the more severe the symptoms

  4. Change in social adaptation ability

    Time frame: 1, 3, 6 months

    The scales of the Vineland II are organized within a three-domain structure: Communication, Daily Living, and Socialization. This structure corresponds to the three broad domains of adaptive functioning by the American Association of Intellectual and Developmental Disabilities: Conceptual, Practical, and Social. In addition, Vineland II offers a Motor Skills Domain and an optional Maladaptive Behavior Index to provide more in-depth information.

    The higher the score, the better the child's development

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 3, 2023
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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