Clinical trial NCT05841927: Clinical Cohort Study of DHA in Neurodevelopmental Disorders
Official title: Clinical Cohort Study of DHA in Neurodevelopmental Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism or Autistic Traits
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Willing to participate in the study, consume the treatment and perform all measurements including developmental or cognitive testing, blood drawing, anthropometry and questionnaires etc.
3. Informed consent signed by parent or caregiver.

Exclusion Criteria:

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

Primary outcomes:
measure: Plasma level concentration of DHA (μg/ml)
timeFrame: 1, 3, 6 months
Secondary outcomes:
measure: Change in developmental assessment
timeFrame: 1, 3, 6 months
measure: Change in autism severity assessed by DSM-5
timeFrame: 1, 3, 6 months
measure: Change in autism severity
timeFrame: 1, 3, 6 months
measure: Change in social adaptation ability
timeFrame: 1, 3, 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiu Xu
role: PRINCIPAL_INVESTIGATOR
References: