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CTRI Number  CTRI/2023/11/060377 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On: 26/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to know whether Vitamin D supplementation can improve the disability due to stroke in 90 days in patients with low levels of vitamin D in blood  
Scientific Title of Study   A Study of Vitamin D Supplementation on the 90 Days Outcome in Acute Ischemic Stroke Patients and Its Correlation with Vitamin D Levels 
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 Jibin Simon 
Designation  Post Graduate 
Affiliation  Saveetha medical college and Hospital 
Address  Department of General Medicine, Saveetha medical college and hospital, Thandalam, Chennai

Kancheepuram
TAMIL NADU
602105
India 
Phone  8921671825  
Fax    
Email  jibinsimon97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajalakshmi KV 
Designation  Professor 
Affiliation  Saveetha medical college and Hospital 
Address  Department of General Medicine, Saveetha medical college and hospital, Thandalam, Chennai

Kancheepuram
TAMIL NADU
602105
India 
Phone  8072909681  
Fax    
Email  drrajeesakthi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jibin Simon 
Designation  Post Graduate 
Affiliation  Saveetha medical college and Hospital 
Address  Department of General Medicine, Saveetha medical college and hospital, Thandalam, Chennai

Kancheepuram
TAMIL NADU
602105
India 
Phone  8921671825  
Fax    
Email  jibinsimon97@gmail.com  
 
Source of Monetary or Material Support  
Saveetha medical college and hospital, Thandalam, Chennai, 602105 
 
Primary Sponsor  
Name  Dr. Jibin Simon 
Address  Post graduate, Saveetha medical college, thandalam, Chennai, 602105 
Type of Sponsor  Other [Self Sponsored] 
 
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 
Dr Jibin Simon  Saveetha Medical college and hospital  Room no:1, Department of General Medicine, Saveetha Medical college and Hospital, thandalam, chennai, 602105
Kancheepuram
TAMIL NADU 		 8921671825

jibinsimon97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Placebo once weekly is supplemented in acute ischemic stroke patients with recorded Vitamin D deficiency or insufficiency during admission for 8 weeks 
Intervention  Vitamin D   Vitamin D 60,000 IU once weekly is supplemented in acute ischemic stroke patients with recorded Vitamin D deficiency or insufficiency during admission for 8 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged more than 40 years of either sex, presenting within 24 hours of the onset of symptoms and diagnosed with acute ischemic stroke by a Brain MRI/CT 
 
ExclusionCriteria 
Details  1. Patients previously diagnosed with Ischemic stroke
2. Patients diagnosed with Hemorrhagic stroke / venous thrombosis
3. Patients with transient ischemic attack.
4. Patients on vitamin D supplementation or received supplementation before the onset of acute ischemic stroke
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Modified rankins score at admission and 90 days  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of recurrent stroke within 90 days  90 days 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   10/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/12/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jibinsimon97@gmail.com].

  6. For how long will this data be available start date provided 01-07-2024 and end date provided 01-07-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a randomized, open-label, parallel control group, single-center, interventional trial evaluating the role of 60,000 IU Vitamin D weekly once supplementation on the 90-day outcome in 86 patients diagnosed with new onset acute ischemic stroke, with Vitamin D deficiency or insufficiency, that will be conducted in a single center in India. The primary outcome measures will be all-cause mortality at 90 days and a Modified Rankin’s Score at admission and 90 days post-rehabilitation. The secondary outcome will be an incidence of recurrent stroke amongst all the study arms.  
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