| CTRI Number |
CTRI/2024/08/072003 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to examine the association between serum vitamin D levels and genetic variation of VDR and dopamine-specific genes in Attention Deficit Hyperactivity Disorder (ADHD) |
|
Scientific Title of Study
|
VDR gene polymorphism and Dopaminergic
and VDR gene expression in Attention Deficit Hyperactivity Disorder (ADHD) |
| Trial Acronym |
ADHD- Attention Deficit Hyperactivity disorder |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayakumar C |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Department of Pediatrics
Amrita Institute of Medical Sciences and Research Centre, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
09446053602 |
| Fax |
|
| Email |
drcjayakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Thomas |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Pharmacy |
| Address |
Department of Pharmacology
Amrita School of Pharmacy
Amrita Vishwa Vidhyapeedam
Kochi
Department of Pharmacology
Amrita School of Pharmacy
Amrita Vishwa Vidhyapeedam
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8851388785 |
| Fax |
|
| Email |
jayamarythomas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mintu Mathew |
| Designation |
Research Scholar |
| Affiliation |
Amrita School of Pharmacy |
| Address |
Department of Pharmacology
Amrita School of Pharmacy
Amrita Vishwa Vidhyapeedam
Kochi
Department of Pharmacology
Amrita School of Pharmacy
Amrita Vishwa Vidhyapeedam
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
08547410561 |
| Fax |
|
| Email |
mintumathew02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Amrita Institute of Medical Sciences and Research Centre, Ponekkara, Kochi-682041 |
| Type of Sponsor |
Research institution |
|
|
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 Jayakumar C |
Amrita Institute of Medical Sciences and Research Centre |
Amrita Institute of Medical Sciences and Research Centre,
Ponekkara, Kochi-682041
Ernakulam
KERALA |
08547410561
mintumathew02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1A. Healthy children (Controls): Children with no current medical illness and family history of any major psychiatric disorder, especially ADHD as defined by ICD-10/ DSM-V.
1B. ADHD patients (Cases): Children diagnosed with ADHD by the paediatrician and the clinical psychologist using the Vanderbilt ADHD rating scale and who are on therapy or not. Comorbid with ODD, SLD, and CD will be included.
2. Willing to withdraw blood and participate in the study after giving consent.
3. Responsible caregiver to provide sufficient information about the participant’s functional status.
|
|
| ExclusionCriteria |
| Details |
1. History of any neurological disorder and psychiatric conditions involving the brain or other central function (eg: History of brain injury, suspected intellectual disability, autism spectrum disorder, narcolepsy, H/O mental retardation (MR), schizophrenia, mania episode, epilepsy, anxiety disorders, bipolar disorder, active suicidal ideation)
2. Use of Anticoagulants
3. Having any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, glaucoma, diabetes or cardiovascular disorders, gallstones, bile duct obstruction, stomach ulcers, or excess stomach acid, abnormality of mineral metabolism eg: Wilson’s disease, hemochromatosis
4. Having any disability that would interfere with participation in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of serum Vitamin D levels will help to rule out the deficiency
VDR gene polymorphism analysis will help to identify the alteration in the VDR gene that might affect the bioconversion of vitamin D in ADHD |
At the baseline visit alone, the blood samples will be collected.
The serum will be separated for vitamin D estimation and DNA will be isolated for polymorphism analysis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The expression analysis of dopamine-specific genes (TH,DRD4,SLC6A3) & VDR will help to elucidate molecular-level changes that will affect the pathophysiology of ADHD.
The genomic analysis of these ADHD-specific genes can be used as an efficient biomarker for ADHD. It will help to improve the treatment outcome by individualizing the treatment modalities accordingly
|
At the baseline visit alone, Blood samples will be collected & mRNA will be isolated
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="3"
Months="1"
Days="1" |
|
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
|
Ø Genetics plays an indispensable role in ADHD, so the discovery of genetic variants linked to ADHD susceptibility plays a crucial role in the advancement of preventive medicine. Several clinical studies have proven the beneficial effect of vitamin D on ADHD, but the mechanism behind this is still unclear. The diagnosis of ADHD is mainly focused on the subjective evidence (behavioural changes) of the patients, but so far, no biological markers are in practice for evaluating the disease status, so dopaminergic genes (VDR,SLC6A3, TH, DRD4) expression from PBMC can be a promising biomarker in ADHD. So, by analyzing the serum vitamin D levels, VDR gene polymorphism from the isolated DNA and evaluating the mRNA expression of the dopamine-specific genes helps elucidate the association of vitamin D in the genomic-level alteration of ADHD ultimately aiding in the individualization of treatment modalities accordingly. |