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NCT05841927Active, not recruiting

Clinical Cohort Study of DHA in Neurodevelopmental Disorders

Source: ClinicalTrials.gov · Last updated 18 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
24 Apr 2023
Start date
1 Dec 2020
Primary completion date
1 Dec 2025
Lead sponsor
Children's Hospital of Fudan University
Diseases
Autism
NCT number
NCT05841927

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 1 Dec 2020 to the primary completion date, 1 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Children with immune deficiency.

Who the study is looking for

  • 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.

Age in the registry: 2 years to 16 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Hospital Of Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.