| CTRI Number |
CTRI/2023/08/057042 [Registered on: 29/08/2023] Trial Registered Prospectively |
| Last Modified On: |
26/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Effect of adjunctive vitamin D supplementation as measured by serum vitamin D And NGF levels in Autism Spectrum Disorder |
|
Scientific Title of Study
|
Effect of adjunctive vitamin D supplementation as measured by serum vitamin D And NGF levels in Autism Spectrum Disorder: An Open-label trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr kanchan Garg |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Room no 131,Al Razi Post Graduate Hostel,Department of Psychiatry, Central institute of psychiatry,Kanke
Ranchi
JHARKHAND
834006
India |
| Phone |
09142091980 |
| Fax |
|
| Email |
k8809962694@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun S Mehta |
| Designation |
Associate Professor |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department office,central Institute of Psychiatry,Kanke,Ranchi Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
09204858189 |
| Fax |
|
| Email |
vs_mehta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun S Mehta |
| Designation |
Associate Professor |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department office,central Institute of Psychiatry,Kanke,Ranchi Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
09204858189 |
| Fax |
|
| Email |
vs_mehta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry,Kanke ranchi,Jharkhand 834004 |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Kanke,Ranchi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr kanchan garg |
Central Institute of Psychiatry |
Consultant room 3,Computer Department,Central Institute of Psychiatry,Kanke,Ranchi Jharkhand
Ranchi
JHARKHAND |
09142091980
k8809962694@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,Central Institute of Psychiatry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Vitamin B complex Supplementation |
vitamin B compelx supplementation in 16 patients of autism spectrum disorder for 12 weeks |
| Intervention |
Vitamin D Supplementation |
Vitamin D Supplementation 3000IU PER DAY FOR 12 WEEKS In 16 Patients with autism spectrum disorder |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children diagnosed with autism spectrum disorder as per ICD11.
2.Childrenwith ASD who are drug naïve or drug free for 2 weeks.
3.Children of either gender up to 10 years of age.
|
|
| ExclusionCriteria |
| Details |
1.Children with known genetic or neurological syndrome with an established link to Autism, history of epilepsy or current seizures, significant medical illness (endocrinopathies), pre-existing liver or kidney disease: sensory or motor impairment that would interfere with the valid completion of study measures.
2.Ongoing use of antiepileptics, steroids, immunosuppressants, bisphosphonates, calcium and vitamin supplements.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFECT OF ADJUNCTIVE VITAMIN D SUPPLEMENTATION IN Patients of AUTISM SPECTRUM DISORDER as measured by ABC & ISAA scales |
baseline 4 week 12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| serum NGF |
baseline 12week |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Studies have established that vitamin D deficiency is one of the risk factors of evolutional neuropsychological disorders including autism (Canell, 2008;Eyeles et al., 2013;Saad et al., 2016) with a few denying the possibility of a deficiency(Molloy et al., 2010; Hashemzadeh et al.,2015) . To date there are twelve human clinical trials on Vitamin D supplementation in ASD (Kittana etal., 2021) which have methodological shortcomings related to study design (case series)(Saad et al.,2016), non- adherence to standard dosing guidelines. (Feng et al., 2017;Bleizgys a,2021)Use of concurrent supplementation (omega fatty acids) and lack of positive correlation between vitamin D level and severity of ASD (Javadfar et al 2020;Mazahery et al., 2019).There is just single study finding NGF levels to be significantly increased in the vitamin D supplementation group in ASD (Ucuz et al., 2014).We therefore decided to conduct present study to evaluate the usefulness of vitamin D Supplementation in ASD, the effects of which are being measured by assessing the serum levels of 25 hydroxycholecalciferol and NGF |