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CTRI Number  CTRI/2025/12/098728 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of Vitamin D3 in stroke patients 
Scientific Title of Study   The effect of Vitamin D3 on clinical outcome of stroke patients in ICU- a prospective randomised double blind 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  Dr Akrity Singh 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of anaesthesia, first floor, near OT complex, Indira Gandhi Institute of medical sciences, Patna 14

Patna
BIHAR
800014
India 
Phone  9431664293  
Fax    
Email  drakrity_s@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Akrity Singh 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of anaesthesia, first floor, near OT complex, IGIMS, Patna 14

Patna
BIHAR
800014
India 
Phone  9431664293  
Fax    
Email  drakrity_s@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Akrity Singh 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of anaesthesia, first floor, near OT complex, Indira Gandhi Institute of Medical Sciences, Patna 14

Patna
BIHAR
800014
India 
Phone  9431664293  
Fax    
Email  drakrity_s@yahoo.co.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Indira Gandhi Institute of Medical Sciences 
Address  Dept of Anaesthesiology and CCM, First floor, ward block,Near OT complex Sheikhpura, IGIMS, Patna 800014 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Akrity Singh  IGIMS Department of Anesthesia  Department of anaesthesia, first floor, near OT complex, IGIMS, Patna 14
Patna
BIHAR 		 9431664293

drakrity_s@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Indira Gandhi Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Single dose intramuscular vitamin D3 200000 IU in stroke patients compared with placebo  Single dose of Intramuscular 200000 IU vitamin D3 in stroke patients with serum vitamin D less than 30ng/ml and normal saline as placebo in other group  
Intervention  Single dose of 200000 IU intramuscular vitamin D3 in stroke patients   Single dose 200000 IU intramuscular vitamin D3 in stroke patients with serum vitamin D levels less than30ng/dl-  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients in the age group of 18-75 years
Patients of both sex
Patients admitting to ICU with cerebrovascular stroke both ischemic and haemorrhagic with NIHSS score 5-24 ,diagnosis confirmed with CT/MRI
 
 
ExclusionCriteria 
Details  patients with vitamin D more than 30ng/ml
patients on vitamin D supplementation
patients with traumatic brain injury  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
will be patient disability of any degree as assessed by the modified Rankin scale 90 days. The modified Rankin Scale (mRS) is a 6-grades scales where 0 means no disability and 6 means death   will be patient disability of any degree as assessed by the modified Rankin scale 90 days. The modified Rankin Scale (mRS) is a 6-grades scales where 0 means no disability and 6 means death - the score and vitamin D assesed at day 1,2,3,4,5,6,7,14,28,90.  
 
Secondary Outcome  
Outcome  TimePoints 
length of ICU stay , number of days of mechanical ventilation (MV days) and mRS clinical outcome at 28 days or at time of discharge or death whichever occurs earlier.   12 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   30/12/2025 
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="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   Rationale- Recently, vitamin D3 has emerged as a potential treatment adjunct for ischemic stroke, as it interferes with the key to survival pathways and shows neuroprotective, anti-inflammatory, regenerative and anti-aging properties in both neuronal and vascular tissue. Past studies on oral and IM supplementation of vitamin D shows mixed results, now IM single dose of vitamin D is available and has not been tested yet. We hypothesise that IM vitamin D3 may have better outcome in quality of stroke patients. Novelty-of our study is the use of single shot IM vitamin D3 , which will have more predictable and effective results. Primary Objective- comparison of modified Rankin scale at 90 days of admission to ICU between the two groups (IV vitamin D and placebo) Secondary objectivecomparison of modified Rankin scale at the time of discharge, Number of days of mechanical ventilation, Change in serum vitamin D3 from baseline to Day5. Methods-upon admission all stroke patients will be assessed on the basis of National institute of health stroke scale (NIHSS). patients with baseline NIHSS score between 5-24 will be included in study and their serum Vitamin D levels will be assessed and IM VitD3 injection of 600000 IU will be given to those with levels less than 30ng/ml. Outcome- will be better neurological outcome in terms of functional ability and disability free days by the neuroprotective and neuro-modulatory effects.   
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