Effect of Vitamin D Therapy in Autism Spectrum Disorder

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

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.

Study Overview

• Status: Recruiting
• Conditions: Effect of Drug
• Intervention / Treatment: Drug: Vitamin D; Other: Habilitation

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amira M. Mansour, MSc; Phone Number: 002 01015006781; Email: dr.amira_mohamed95@yahoo.com

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Recruiting
    • Mansoura University Hospital
    • Contact: Tamer S. Abou-Elsaad, Professor; Phone Number: 002 01005192300; Email: taboelsaad@hotmail.com
    • Principal Investigator: Amira M. Mansour, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D therapy and habilitation; 40 ASD children receiving Vitamin D therapy and habilitation	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
Other: Habilitation; 40 ASD children receiving habilitation	Other: Habilitation; Habilitation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Amira M. Mansour, MSc, Phoniatric unit, ORL department, faculty of medicine, Mansoura university

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: MansouraA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Vitamin D level, interleukin 4 in ASD
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: https://www.mans.edu.eg/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No