| CTRI Number |
CTRI/2025/11/097318 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Low blood calcium level a warning sign for dengue in children |
|
Scientific Title of Study
|
Hypocalcemia as a marker of disease severity in children with dengue |
| 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 Anjali Kumari |
| Designation |
Post graduate |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES DELHI |
| Address |
Paediatrics department OPD room no 10 guru teg bahadur hospital
Paediatrics department OPD room no 10 guru teg bahadur hospital
North East
DELHI
110095
India |
| Phone |
7321858466 |
| Fax |
|
| Email |
anjalibhagat305@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Narang |
| Designation |
Director Professor |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES DELHI |
| Address |
Paediatrics department OPD room no 10 Guru teg bahadur hospital
Paediatrics department OPD room no 10 Guru teg bahadur hospital
North East
DELHI
110095
India |
| Phone |
9625900829 |
| Fax |
|
| Email |
manish_2710@yahoo.com. |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Kumari |
| Designation |
Post graduate |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES DELHI |
| Address |
Paediatrics department OPD room no 10 guru teg bahadur hospital
Paediatrics department OPD room no 10 guru teg bahadur hospital
North East
DELHI
110095
India |
| Phone |
7321858466 |
| Fax |
|
| Email |
anjalibhagat305@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences Guru Teg Bahadur Hospital Delhi |
| Address |
University College of Medical Sciences Guru Teg Bahadur Hospital Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Anjali Kumari |
University College of Medical Sciences And Guru Teg Bahadur Hospital |
Department of Pediatrics room no.10 opd University College of Medical Sciences
And Guru Teg Bahadur Hospital New Delhi
North East
DELHI |
7321858466
anjalibhagat305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ISTITUTIONAL ETHICS COMMITEE HUMAN RESEARCH UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI, DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Probable dengue and confirmed dengue as per WHO guidelines of age 6 months to 12 years
Admission within first 5 days of fever
|
|
| ExclusionCriteria |
| Details |
Children with known metabolic or endocrine disorders of calcium metabolism
Children with chronic renal or hepatic disease or malignancy
Patients already receiving calcium or vitamin D supplements
Patients on steroids or immunosuppressives
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with hypocalcemia among those classified with severe dengue versus non-severe dengue. |
within 24 hours of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation coefficients between calcium levels and
Platelet count and Hematocrit
Incidence of complications ( shock, bleeding, organ involvement) in hypocalcemic vs normocalcemic patients.
|
within 24 hours of admission |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
25/11/2025 |
| 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="0"
Days="15" |
|
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 observational study, conducted at GTB Hospital from August 2025 to November 2026, investigates whether low serum calcium levels (hypocalcemia) can serve as a predictor of disease severity in pediatric dengue patients aged 6 months to 12 years. The study aims to correlate calcium levels with clinical severity, platelet count, hematocrit, and complications. By identifying hypocalcemia early, the research hopes to improve monitoring and outcomes in children with dengue. A total of 42 severe dengue cases will be recruited, along with all non-severe cases.
|