Effect of Vitamin D Therapy in Autism Spectrum Disorder

NCT05595044 | Unknown Phase 1

• 1 other identifier: MansouraA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Vitamin D therapy and habilitation

EXPERIMENTAL

40 ASD children receiving Vitamin D therapy and habilitation

Drug: Vitamin D; Other: Habilitation

Habilitation

OTHER

40 ASD children receiving habilitation

Other: Habilitation

Interventions

Vitamin D DRUG

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.

Vitamin D therapy and habilitation

Habilitation OTHER

Habilitation

Habilitation; Vitamin D therapy and habilitation

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

Vitamin D; Rehabilitation

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Amira M. Mansour, MSc

  Phoniatric unit, ORL department, faculty of medicine, Mansoura university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira M. Mansour, MSc

CONTACT

01015006781; dr.amira_mohamed95@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Two study groups. One group receiving vitamin D plus habilitation and the other group receiving habilitation only

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 26, 2022
• Study Start: October 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 years
• Access Criteria: https://www.mans.edu.eg/

Locations

EG (1)