Effect of Drug
Conditions
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).
Interventions
DRUGVitamin D
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.
OTHERHabilitation
Habilitation
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Intervention model description
Two study groups. One group receiving vitamin D plus habilitation and the other group receiving habilitation only
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Delayed language development due to ASD. 2. Good nutritional status (Normal weight and height using growth charts, no Anemia and no clinical evidence of vitamin deficiency). 3. Normal hearing and vision.
Exclusion criteria
1. History of vitamin D supplementation, drugs modulating immune system as steroid and drug formula containing vitamin D as cod liver oil. 2. Known chronic disease. 3. Known neurological disorders or psychiatric disorders. 4. Known autoimmune or gastrointestinal disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| language ability test | 4 months | language test for assessment of language age |
| CARS questionnaire for assessment of ASD severity | 4 months | CARS questionnaire for assessment of ASD severity |
| Inflammatory marker | 4 months | Assessment of serum interleukin 4 by ELISA technique |
| Serum vitamin D | 6 weeks | Assessment of serum vitamin D by ADVIA Centaur® Vitamin D Total (VitD) assay |
Countries
Egypt
Contacts
Primary ContactAmira M. Mansour, MSc
Outcome results
None listed