Autism or Autistic TraitsNCT05841927
Clinical Cohort Study of DHA in Neurodevelopmental Disorders
A study testing Docosahexaenoic acid supplement in people with Autism or Autistic Traits, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Autism or Autistic Traits
- What is being tested?
- Docosahexaenoic acid supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Autism or Autistic Traits
- Being tested
- Docosahexaenoic acid supplement, ASD placebo
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acid supplementDietary supplement
Docosahexaenoic acid supplement
ASD placeboDietary supplement
ASD placebo
| Study group | Role | What they receive |
|---|---|---|
| ASD active | Experimental | Dietary Supplement: Docosahexaenoic acid 200mg DHA once, twice a day Receives: Dietary Supplement: Docosahexaenoic acid supplement |
| ASD placebo | Placebo comparator | Dietary Supplement: Placebo dietary intervention Vitamin D 400IU once, once a day Receives: Dietary Supplement: ASD placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 3, 6 months
Secondary outcomes (4)
Change in developmental assessment
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.
Measured: 1, 3, 6 months
Change in autism severity assessed by DSM-5
ASD severity was based on the DSM-5 administrated by certified clinicians. The higher the score, the more severe the symptoms
Measured: 1, 3, 6 months
Change in autism severity
ASD severity was based on the ADOS-2 administrated by certified clinicians. The higher the score, the more severe the symptoms
Measured: 1, 3, 6 months
Change in social adaptation ability
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
Measured: 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Dec 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism or Autistic TraitsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiu Xu, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841927
- Sponsor's protocol ID
- DHA_CHFU
- Status last verified
- Feb 2025
- First submitted
- 24 Apr 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Cohort Study of DHA in Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT05841927
- Acronym / sponsor ID
- DHA_CHFU
- Conditions
- Autism or Autistic Traits
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD active | Experimental | Dietary Supplement: Docosahexaenoic acid supplementDietary Supplement: Docosahexaenoic acid 200mg DHA once, twice a day |
| ASD placebo | Placebo comparator | Dietary Supplement: ASD placeboDietary Supplement: Placebo dietary intervention Vitamin D 400IU once, once a day |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosahexaenoic acid supplementDocosahexaenoic acid supplement | Dietary supplement | ASD active |
| ASD placeboASD placebo | Dietary supplement | ASD placebo |
Primary outcome
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.
4 secondary outcomes
Change in developmental assessment
Time frame: 1, 3, 6 months
Change in autism severity assessed by DSM-5
Time frame: 1, 3, 6 months
Change in autism severity
Time frame: 1, 3, 6 months
Change in social adaptation ability
Time frame: 1, 3, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiu Xu principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docosahexaenoic acid supplement in people with Autism or Autistic Traits, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma level concentration of DHA (μg/ml) (time frame: 1, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.