Effect of DrugPhase 1NCT05595044
Effect of Vitamin D Therapy in Autism Spectrum Disorder
A Phase 1 study testing Vitamin D and Habilitation in people with Effect of Drug, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Vitamin D and Habilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university hospital
Al Mansurah, 35516
Tamer S. Abou-Elsaad, Professor, 01005192300 ext. 002, taboelsaad@hotmail.com
Amira M. Mansour, MSc
About this study
Official title: 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.
Read the 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).
- Conditions
- Effect of Drug
- Being tested
- Vitamin D, Habilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
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.
HabilitationOther
Habilitation
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D therapy and habilitation | Experimental | 40 ASD children receiving Vitamin D therapy and habilitation Receives: Drug: Vitamin D; Other: Habilitation |
| Habilitation | Other | 40 ASD children receiving habilitation Receives: Other: Habilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
language ability test
language test for assessment of language age
Measured: 4 months
CARS questionnaire for assessment of ASD severity
CARS questionnaire for assessment of ASD severity
Measured: 4 months
Inflammatory marker
Assessment of serum interleukin 4 by ELISA technique
Measured: 4 months
Serum vitamin D
Assessment of serum vitamin D by ADVIA Centaur® Vitamin D Total (VitD) assay
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Oct 2020
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two study groups. One group receiving vitamin D plus habilitation and the other group receiving habilitation only
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohamed Mansour, Mansoura University
- Investigators
- Amira M. Mansour, MSc, Principal investigator, Phoniatric unit, ORL department, faculty of medicine, Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595044
- Sponsor's protocol ID
- MansouraA
- Status last verified
- Aug 2023
- First submitted
- 18 Oct 2022
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Vitamin D level, interleukin 4 in ASD
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serum Vitamin D Correction on the Inflammatory Markers and Habilitation Outcome in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05595044
- Acronym / sponsor ID
- MansouraA
- Conditions
- Effect of Drug
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two study groups. One group receiving vitamin D plus habilitation and the other group receiving habilitation only
| Arm | Type | Receives |
|---|---|---|
| Vitamin D therapy and habilitation | Experimental | Drug: Vitamin D, Other: Habilitation40 ASD children receiving Vitamin D therapy and habilitation |
| Habilitation | Other | Other: Habilitation40 ASD children receiving habilitation |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DASD 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. | Drug | Vitamin D therapy and habilitation |
| HabilitationHabilitation | Other | Habilitation, Vitamin D therapy and habilitation |
Primary outcome
language ability test
Time frame: 4 months
language test for assessment of language age
CARS questionnaire for assessment of ASD severity
Time frame: 4 months
CARS questionnaire for assessment of ASD severity
Inflammatory marker
Time frame: 4 months
Assessment of serum interleukin 4 by ELISA technique
Serum vitamin D
Time frame: 6 weeks
Assessment of serum vitamin D by ADVIA Centaur® Vitamin D Total (VitD) assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Yes. Vitamin D level, interleukin 4 in ASD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira M. Mansour, MSc principal investigator
Phoniatric unit, ORL department, faculty of medicine, Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D and Habilitation in people with Effect of Drug, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira M. Mansour, MSc (01015006781 ext. 002, dr.amira_mohamed95@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
language ability test (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.