| CTRI Number |
CTRI/2025/10/096172 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Intravenous Calcium for Facilitating Recovery in Children Hospitalized with Pneumonia and low blood calcium without symptoms |
|
Scientific Title of Study
|
Intravenous Calcium for Facilitating Recovery in Children Hospitalized with Pneumonia and Asymptomatic Hypocalcemia: A Randomized Controlled Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivek Vats |
| Designation |
Post Graduate Resident |
| Affiliation |
University college of medical sciences and GTB Hospital |
| Address |
Department of pediatrics,MCH Block,University college of medical sciences and GTB Hospital,Tahirpur road,GTB Enclave,Dilshad Garden,New Delhi
North East
DELHI
110095
India |
| Phone |
9654031924 |
| Fax |
|
| Email |
Vivekvats1011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dheeraj Shah |
| Designation |
Director Professor |
| Affiliation |
University college of medical sciences and GTB Hospital |
| Address |
Principal,University college of medical sciences and GTB Hospital,Tahirpur road,GTB Enclave,Dilshad Garden,New Delhi
North East
DELHI
110095
India |
| Phone |
8851872472 |
| Fax |
|
| Email |
shahdheeraj@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dheeraj Shah |
| Designation |
Director Professor |
| Affiliation |
University college of medical sciences and GTB Hospital |
| Address |
Principal,University college of medical sciences and GTB Hospital,Tahirpur road,GTB Enclave,Dilshad Garden,New Delhi
North East
DELHI
110095
India |
| Phone |
8851872472 |
| Fax |
|
| Email |
shahdheeraj@hotmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital |
|
|
Primary Sponsor
|
| Name |
Vivek Vats |
| Address |
2,Tahirpur road,GTB Enclave ,Dilshad Garden,New Delhi, 110095 |
| 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 |
| Dr Vivek Vats |
UCMS And GTB Hospital |
Department of Pediatrics,6th floor, MCH Block, Tahirpur road, GTB Enclave, Dilshad Garden,
North East
DELHI |
9654031924
VIVEKVATS1011@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
The control group will only recieve standard treatment of pneumonia. The standard first line antibiotic for pneumonia will be ceftriaxone and supportive oxygen therapy will be given. |
| Intervention |
Injection Calcium Gluconate |
Injection calcium gluconate (10% w/v equivalent to elemental calcium of 8.9 mg/mL or 0.45 mEq/mL of calcium) and 5% dextrose will be mixed in 1:1 ratio to prepare the infusion. The participants allocated to intervention group will receive infusion of 10% calcium gluconate on the day of enrolment at a dose of 500 mg/kg/24 hours equivalent to 44.5 mg/kg/24 hours of elemental calcium divided every 6 hourly as a slow infusion administered over one hour, in addition to standard treatment. The infusion will be continued for 48 hours after enrolment. The control group will receive standard treatment only. The infusion will be given while monitoring heart rate and oxygen saturation through multipara monitors. Infusion will be stopped if the child develops bradycardia or any arrythmia. Infusion will be restarted at a slower rate than before after heart rate reaches the normal range. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with pneumonia/severe pneumonia based on WHO classification, requiring hospitalization and detected to be having asymptomatic hypocalcemia |
|
| ExclusionCriteria |
| Details |
1.Children with known chronic comorbidities (e.g., congenital heart disease, immunodeficiency, neurological disorders).
2.Severe acute malnutrition
3.Children with complicated pneumonia (Empyema, lung abscess, massive pleural effusion)
4.Children presenting with shock, convulsions, requiring resuscitation or mechanical ventilation before enrolment.
5.Children who received oral/parenteral calcium within last 7 days before enrolment
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical resolution of pneumonia |
Time for clinical resolution of pneumonia (in hours) from the time of enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Resolution of chest retractions, or tachypnea
2.Oxygen requirement
3.Hospital stay
4.Serum calcium
5.Local & systemic adverse events (local site reactions, pain, swelling, redness at injection site, bradycardia, arrythmia, hypotension)
|
1.Time to resolution of chest retractions (in hours), or tachypnea (in hours) from time of enrolment
2.Duration of oxygen requirement (in hours)
3.Duration of hospital stay (in days)
4.Serum calcium at 24 & 48 hours after starting intravenous calcium gluconate
5.The frequency of local & systemic adverse events (local site reactions, pain, swelling, redness at injection site, bradycardia, arrythmia, hypotension) during 48 hours of intravenous calcium therapy |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim of the study is to evaluate the efficacy and safety of intravenous calcium supplementation for enhancing recovery in children hospitalized with pneumonia and asymptomatic hypocalcemia where serum calcium is less than 8.5 mg/dL. Rationale of the study is that calcium plays an essential role in the contraction of respiratory muscles, low serum calcium levels can contribute to respiratory weakness and potentially exacerbate hypoxemia and respiratory failure. Rapid correction of hypocalcemia may help improve respiratory mechanics and enhance recovery in pneumonia. It is hypothesized that giving intravenous calcium to children with pneumonia and asymptomatic hypocalcemia will show faster recovery from illness. |