| CTRI Number |
CTRI/2019/11/022098 [Registered on: 21/11/2019] Trial Registered Prospectively |
| Last Modified On: |
31/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of vitamin D administration in critically ill vitamin D deficient patients |
|
Scientific Title of Study
|
Effect of vitamin D administration in critically ill vitamin D deficient patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urmila Jhamb |
| Designation |
Director Professor |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
ujhamb@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrityunjay Sakkarwal |
| Designation |
PG Resident |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI
110002
India |
| Phone |
9654001779 |
| Fax |
|
| Email |
mrityunosagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrityunjay Sakkarwal |
| Designation |
PG Resident |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI
110002
India |
| Phone |
9654001779 |
| Fax |
|
| Email |
mrityunosagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital, New 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 Urmila Jhamb |
Maulana Azad Medical College and associated Lok Nayak Hospital |
Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI |
996804309
ujhamb@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cholecalciferol |
Single Intramuscular cholecalciferol injection 10,000 U/kg stat. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All the children 1month to 12 years of age requiring PICU admission, who are vitamin D deficient. |
|
| ExclusionCriteria |
| Details |
Children with hypocalcaemia, known renal disease, urolithiasis or nephrocalcinosis, parathyroid disease or pituitary dysfunction. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of single high dose vitamin D supplementation as compared to placebo on the outcome of vitamin D deficient patients admitted to PICU i.e. difference in: -
Mortality
Duration of PICU stay
Need for mechanical ventilation
Duration of ventilation in ventilated patients
Need for cardiovascular support as boluses or inotropes. |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in vitamin D levels after giving single high dose vitamin D supplementation in critically ill vitamin D deficient children |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
30/11/2019 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Over
the last several years, multiple studies have demonstrated that vitamin D
deficiency is a preexisting and acquired disorder in critical illness, and its
prevalence is probably greater than once believed. 50-84% of PICU
patients may have vitamin D deficiency.
Vitamin D deficiency has been thought not only to be common
but also a potentially modifiable risk factor for severity and clinical outcome
during critical illness. Even a subclinical
Vitamin D deficient state may predispose to neurologic, cardiovascular,
respiratory and immune pathology and these organ systems are vital for early
recovery.
However, there is
very little literature available to support the use of vitamin D supplementation
to improve morbidity and mortality in patients admitted to ICU and vitamin D
deficiency is rarely replaced adequately, if at all, in these patients.
|