Effect of Vitamin D Therapy in Autism Spectrum Disorder

Phase 1

Recruiting

• Conditions: Effect of Drug
• Interventions: Other: Habilitation; Drug: Vitamin D

• Registration Number: NCT05595044
• Lead Sponsor: Mansoura University

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).

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Habilitation	Habilitation	40 ASD children receiving habilitation
Vitamin D therapy and habilitation	Vitamin D	40 ASD children receiving Vitamin D therapy and habilitation
Vitamin D therapy and habilitation	Habilitation	40 ASD children receiving Vitamin D therapy and habilitation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansoura, Egypt