Effect of Vitamin D Therapy in Autism Spectrum Disorder

Effect of Drug Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595044
• Other study ID #: MansouraA
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: Mansoura University
• Contact: Amira M. Mansour, MSc
• Phone: 01015006781
• Email: dr.amira_mohamed95[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Effect of Drug

Intervention

Drug:
• Vitamin 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.

Other:
• Habilitation
Habilitation

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

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