Effect of Vitamin D Therapy in Autism Spectrum Disorder

Study Overview
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Brief Summary
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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
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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).

Official Title
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Impact of Serum Vitamin D Correction on the Inflammatory Markers and Habilitation Outcome in Children With Autism Spectrum Disorder

Conditions
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Effect of Drug

Intervention / Treatment
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* Drug: Vitamin D
* Other: Habilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two study groups. One group receiving vitamin D plus habilitation and the other group receiving habilitation only
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D therapy and habilitation<br>40 ASD children receiving Vitamin D therapy and habilitation | Drug: Vitamin D<br>* 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.<br>Other: Habilitation<br>* Habilitation<br>|
| Other: Habilitation<br>40 ASD children receiving habilitation | Other: Habilitation<br>* Habilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| language ability test | language test for assessment of language age | 4 months | 
| CARS questionnaire for assessment of ASD severity | CARS questionnaire for assessment of ASD severity | 4 months | 
| Inflammatory marker | Assessment of serum interleukin 4 by ELISA technique | 4 months | 
| Serum vitamin D | Assessment of serum vitamin D by ADVIA Centaur® Vitamin D Total (VitD) assay | 6 weeks |