Assessment of Vitamin D Level in Children With Autism in Assiut University Children Hospital

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05759455
Collaborator
(none)
50
3

Study Details

Study Description

Brief Summary

In the present study, we aim to evaluate the serum level of 25 hydrxy vitamin D in autistic children .

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: vitamin d

Detailed Description

Autism spectrum disorder (ASD) is a group of neurodevelopmental disorders characterized by impaired social interaction and communication, repetitive and stereotyped behaviors, and restricted interests ( Lord et al,2018).

Autism is becoming increasingly common. Recently, the Centers for Disease Control and Prevention reported that the prevalence of autism among 8-year-old children in the United States in 2016 was 1/54, with a 4.3:1 ratio of males to females ( Maenner et al ,2020).

Autistic individuals manifest problematic behaviors, such as attacking, self-injury, resistance to orders, and failure of normal conversation, and are usually comorbid with social-anxiety, attention-deficit/hyperactivity, sleep-wake disorders, and obsessive-compulsive disorders. As such, it is difficult for them to obtain the same education levels as their neurotypical peers, find full-time jobs, or live independently ( Lord et al,2018),( Lai et al , 2019) .

Fortunately, evidence indicates that appropriate and early intervention could help autistic individuals improve their symptoms and life quality (Landa ., 2018).

Notably, research shows that nutritional and dietary intervention is an effective way to improve nutritional status, non-verbal IQ, and autism symptoms (Adams et al ,2018). Therefore, it is essential to identify physiological dysfunction and abnormal nutritional status in autistic individuals and then take corresponding interventions.

Autism is a multifactorial disorder resulting from an interaction of genetic and environmental factors. Hundreds of autism risk genes and various environmental factors have been discovered ( Linhong et al 2020) ( Lord et al , 2020). Possible environmental factors include folic acid deficiency, neonatal hypoxia, maternal obesity, and gestational diabetes mellitus( Lord et al , 2020).

Recently, emerging evidence suggests that vitamin D deficiency might be an unfavorable factor of autism (Mazahery et al, 2016).

Vitamin D is a steroid hormone; it is primarily synthesized in the skin under UV-B light, and a small amount is derived from dietary intake (Saraff et al , 2016).

Although the underlying mechanisms between vitamin D and autism are unclear, there is some biological evidence indicating the potential link. Vitamin D-metabolizing enzymes and vitamin D receptors are widely expressed in immune cells, the placenta, and the developing and adult brain; high levels of vitamin D surface receptor (protein disulfide isomerase family A members 3, PDIA3) are found in the cortex and hippocampus, which suggests the association between vitamin D, and brain development and function (Bivona G., et al, 2019)( Landel et al, 2018)( Wang et al, 2012).

Indeed, vitamin D has important effects on brain development and function, including neuronal differentiation, proliferation and apoptosis, regulating synaptic plasticity, the ontogeny of the dopaminergic system, immunomodulation, and reducing oxidative burden (Bivona et al, 2019).

In addition, vitamin D plays an important role in the regulation of gene expression. One study showed that 223 ASD risk genes in the SFARI database were vitamin D3-sensitive genes, which meant that these ASD related genes might be regulated by vitamin D (Trifonova et al, 2019).

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Vitamen D in Autism
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Assessment of Vitamin D level in Children with Autism in assiut university children hospital [2 years]

    In the present study, we aim to evaluate the serum level of 25 hydrxy vitamin D in autistic children .

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Months to 18 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patient who full filled the diagnostic criteria of autism spectrum disorder according to DSM-IV.
Exclusion Criteria:
  • 1)Children using vitamin D supplement. 2)patients with associated congenital malformation. 3)patients with chromosomal abnormalities. 4)patients with chronic physical illness. 5)patients with epilepsy. 6)patients with hepatic or renal disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ahmed Abdelmoneim Ahmed, assiutU, Assiut University
ClinicalTrials.gov Identifier:
NCT05759455
Other Study ID Numbers:
  • vitamin d in autism
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2023