| CTRI Number |
CTRI/2024/01/061577 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Real Time Identification of Pathogens Causing ARTI and Role of Vitamin D in Children |
|
Scientific Title of Study
|
Real time identification of common pathogens causing acute respiratory tract infection in children below 14 years of age and role of vitamin D supplementation in reduction of ARTI |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayathri G |
| Designation |
Research Scholar |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Microbiology, SRM Medical College Hospital and Research Centre, SRM IST, SRM Nagar, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8838079356 |
| Fax |
|
| Email |
gg4730@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Nalini Jayanthi |
| Designation |
Prof and Head, Department of Respiratory Medicine |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Deparment of Respiratory Medicine, SRM Medical College Hospital and Research Centre, SRM IST, SRM Nagar, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444226783 |
| Fax |
|
| Email |
nalinijayanthi59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Nalini Jayanthi |
| Designation |
Prof and Head, Department of Respiratory Medicine |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Deparment of Microbiology, SRM Medical College Hospital and Research Centre, SRM IST, SRM Nagar, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444226783 |
| Fax |
|
| Email |
nalinijayanthi59@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Gayathri G |
| Address |
Deparment of Microbiology, SRM Medical College Hospital and Research Centre, SRM IST, SRM Nagar, Kattankulathur, Tamil Nadu - 603203 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Gayathri G |
SRM Medical College Hospital and Research Centre |
Deparment of Microbiology, SRM Medical College Hospital and Research Centre, SRM IST, SRM Nagar, Kattankulathur, Tamil Nadu - 603203
Kancheepuram
TAMIL NADU |
8838079356
gg4730@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcirol Sachet
|
Cholecalciferol granules 60000 IU/gm, Weekly once for 3 months orally |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1) Children below 14yrs of age in hospitalized children.
2) Children with acute respiratory infection.
|
|
| ExclusionCriteria |
| Details |
1) Newborn below 1 month.
2) Infants with congenital disorders (Heart defects, Neural defects, Down syndrome, etc…)
3) Infants with immunodeficiency.
4) Patients having chronic inflammatory, autoimmune disorders, renal disease, and malignancies.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Various pathogens responsible for ARTI in children will be identified & The percentage of bacterial, viral and coinfections will be calculated. |
2 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We can find whether Vitamin-D supplementation is associated with the severity of infection. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
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 |
|
Date of First Enrollment (India)
|
20/01/2024 |
| 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="2"
Months="0"
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
|
This study is a stratified randomized control trail in which participants are selected based on the inclusion and exclusion criteria. Identification of various pathogens responsible for ARTI in children below 14 yrs of age and percentage of bacterial, viral and bacterial - viral coinfection will be calculated. The level of vitamin D and Interleukin 6 (IL6) in serum will be checked and the participants with vitamin D deficiency and insufficiency will be identified. The participants where divided into three groups (No Pneumonia, Pneumonia and Severe Pneumonia) based on the symptoms and each group will be divided into two groups (Intervention & Control) based on the vitamin D deficiency and insufficiency. The intervention group will receive vitamin D supplement 60000 IU, weekly once for 3 months. patients will be followed up during their intervention. After a period of 3 months of intervention, the serum Vitamin D, IL6 level and the Persistent infection will be checked. Primary outcome will be the identification of various pathogens and calculation of percentage of each pathogen and its coinfection will be assessed. Secondary outcome is the level of vitamin D is associated with the severity of infection / helps in the reduction of recurrent infection. |