Effect of Vitamin D Therapy in Autism Spectrum Disorder
Primary Purpose
Effect of Drug
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
Habilitation
Sponsored by
About this trial
This is an interventional treatment trial for Effect of Drug
Eligibility Criteria
Inclusion Criteria:
- Delayed language development due to ASD.
- Good nutritional status (Normal weight and height using growth charts, no Anemia and no clinical evidence of vitamin deficiency).
- Normal hearing and vision.
Exclusion Criteria:
- History of vitamin D supplementation, drugs modulating immune system as steroid and drug formula containing vitamin D as cod liver oil.
- Known chronic disease.
- Known neurological disorders or psychiatric disorders.
- Known autoimmune or gastrointestinal disorders.
Sites / Locations
- Mansoura university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Vitamin D therapy and habilitation
Habilitation
Arm Description
40 ASD children receiving Vitamin D therapy and habilitation
40 ASD children receiving habilitation
Outcomes
Primary Outcome Measures
language ability test
language test for assessment of language age
CARS questionnaire for assessment of ASD severity
CARS questionnaire for assessment of ASD severity
Inflammatory marker
Assessment of serum interleukin 4 by ELISA technique
Serum vitamin D
Assessment of serum vitamin D by ADVIA Centaur® Vitamin D Total (VitD) assay
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05595044
Brief Title
Effect of Vitamin D Therapy in Autism Spectrum Disorder
Official Title
Impact of Serum Vitamin D Correction on the Inflammatory Markers and Habilitation Outcome in Children With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura 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
The aim of this work is to study the adjuvant effect of vitamin D supplementation on inflammatory marker (IL4) and habilitation outcome in children with Autism Spectrum Disorder in order to evaluate its efficiency as a treatment option based on correction of immune dysfunction.
Detailed Description
Vitamin D is one of environmental factors potentially modulating brain development and functioning. Vitamin D3 deficiency during pregnancy and early childhood is suggested to be one of several risk factors for development of ASD in genetically predisposed individuals (Cies´lin´ska et al., 2017). Many studies e.g (Eyles et al., 2013; Grant and Sole, 2009; Noriega and Savelkoul, 2014) suggested that vitamin D has an important role as a neuroactive steroid, which can affect neuronal differentiation, axonal connectivity and brain structure and function. Vitamin D has been increasingly recognized for its immunomodulatory role and has been implicated in the pathogenesis of autoimmune disorders. Also it has numerous and dynamic effects on the immune system, ranging from altering T cell responses and regulating cytokine pathways (Kocˇovská et al., 2017). So from this point of view, this study will be conducted to show adjuvant effect of vitamin D supplementation on ASD children at clinical level and inflammatory marker (IL4).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Drug
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Two study groups. One group receiving vitamin D plus habilitation and the other group receiving habilitation only
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D therapy and habilitation
Arm Type
Experimental
Arm Description
40 ASD children receiving Vitamin D therapy and habilitation
Arm Title
Habilitation
Arm Type
Other
Arm Description
40 ASD children receiving habilitation
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
ASD children with vitamin D insufficiency and deficiency will receive vitamin D with dose 300 IU/KG/ day not exceed 5000IU/day for 6 weeks then revaluate serum level of vitamin D if they reach normal level of vitamin D they will receive vitamin D 1000IU/ day till the end of 4 months.
Intervention Type
Other
Intervention Name(s)
Habilitation
Intervention Description
Habilitation
Primary Outcome Measure Information:
Title
language ability test
Description
language test for assessment of language age
Time Frame
4 months
Title
CARS questionnaire for assessment of ASD severity
Description
CARS questionnaire for assessment of ASD severity
Time Frame
4 months
Title
Inflammatory marker
Description
Assessment of serum interleukin 4 by ELISA technique
Time Frame
4 months
Title
Serum vitamin D
Description
Assessment of serum vitamin D by ADVIA Centaur® Vitamin D Total (VitD) assay
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Delayed language development due to ASD.
Good nutritional status (Normal weight and height using growth charts, no Anemia and no clinical evidence of vitamin deficiency).
Normal hearing and vision.
Exclusion Criteria:
History of vitamin D supplementation, drugs modulating immune system as steroid and drug formula containing vitamin D as cod liver oil.
Known chronic disease.
Known neurological disorders or psychiatric disorders.
Known autoimmune or gastrointestinal disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira M. Mansour, MSc
Phone
01015006781
Ext
002
Email
dr.amira_mohamed95@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira M. Mansour, MSc
Organizational Affiliation
Phoniatric unit, ORL department, faculty of medicine, Mansoura university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamer S. Abou-Elsaad, Professor
Phone
01005192300
Ext
002
Email
taboelsaad@hotmail.com
First Name & Middle Initial & Last Name & Degree
Amira M. Mansour, MSc
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Vitamin D level, interleukin 4 in ASD
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
https://www.mans.edu.eg/
Learn more about this trial
Effect of Vitamin D Therapy in Autism Spectrum Disorder
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