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Clinical Cohort Study of DHA in Neurodevelopmental Disorders

Primary Purpose

Autism or Autistic Traits

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Docosahexaenoic acid supplement
ASD placebo
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autism or Autistic Traits

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASD active

ASD placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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
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

Full Information

First Posted
April 24, 2023
Last Updated
May 2, 2023
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05841927
Brief Title
Clinical Cohort Study of DHA in Neurodevelopmental Disorders
Official Title
Clinical Cohort Study of DHA in Neurodevelopmental Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism or Autistic Traits

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASD active
Arm Type
Experimental
Arm Description
Dietary Supplement: Docosahexaenoic acid 200mg DHA once, twice a day
Arm Title
ASD placebo
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement: Placebo dietary intervention Vitamin D 400IU once, once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Docosahexaenoic acid supplement
Intervention Description
Docosahexaenoic acid supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
ASD placebo
Intervention Description
ASD placebo
Primary Outcome Measure Information:
Title
Plasma level concentration of DHA (μg/ml)
Description
Detection and analysis of free fatty acid substances were performed using an Agilent 7890B gas chromatograph system coupled with a Agilent 5977B mass spectrometer.
Time Frame
1, 3, 6 months
Secondary Outcome Measure Information:
Title
Change in developmental assessment
Description
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.
Time Frame
1, 3, 6 months
Title
Change in autism severity assessed by DSM-5
Description
ASD severity was based on the DSM-5 administrated by certified clinicians. The higher the score, the more severe the symptoms
Time Frame
1, 3, 6 months
Title
Change in autism severity
Description
ASD severity was based on the ADOS-2 administrated by certified clinicians. The higher the score, the more severe the symptoms
Time Frame
1, 3, 6 months
Title
Change in social adaptation ability
Description
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
Time Frame
1, 3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiu Xu
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Cohort Study of DHA in Neurodevelopmental Disorders

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