Vitamin D therapy for children with Autism Spectrum Disorder
Impact of Serum Vitamin D Correction on the Inflammatory Markers and Habilitation Outcome in Children With Autism Spectrum Disorder
This study is testing if giving vitamin D to children with Autism Spectrum Disorder can help improve their symptoms and overall health by looking at how it affects their immune system and brain development.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Mansoura) |
| Trial ID | NCT05595044 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of vitamin D supplementation on inflammatory markers and habilitation outcomes in children diagnosed with Autism Spectrum Disorder (ASD). It aims to evaluate the potential of vitamin D as an adjuvant treatment by addressing immune dysfunction associated with ASD. The research will assess how vitamin D influences brain development and immune responses, particularly focusing on the inflammatory marker IL4. The study is designed to provide clinical insights into the role of vitamin D in managing ASD symptoms.
Who should consider this trial
Good fit: Ideal candidates are children with delayed language development due to Autism Spectrum Disorder who are in good nutritional status.
Not a fit: Patients with a history of vitamin D supplementation or those with chronic, neurological, psychiatric, autoimmune, or gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new therapeutic approach to improve outcomes for children with Autism Spectrum Disorder.
How similar studies have performed: While the role of vitamin D in neurodevelopment is being explored, this specific approach to treating ASD with vitamin D supplementation is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mansoura
- Mansoura university hospital — Mansoura, Egypt (Recruiting)
Study contacts
- Principal investigator: Amira M. Mansour, MSc — Phoniatric unit, ORL department, faculty of medicine, Mansoura university
- Study coordinator: Amira M. Mansour, MSc
- Email: dr.amira_mohamed95@yahoo.com
- Phone: 01015006781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.