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CTRI Number  CTRI/2020/03/024109 [Registered on: 20/03/2020] Trial Registered Prospectively
Last Modified On: 19/03/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational registry study 
Study Design  Other 
Public Title of Study   A Study to Determine the Patient and Disease Profile and Treatment provided to Patients who do not have optimum levels of Vitamin D 
Scientific Title of Study   A Study to Determine the Patient and Disease Profile and Treatment Paradigm in Adult Patients Diagnosed with Vitamin D Deficiency/Insufficiency 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
EPIDI075_Version_1_Dated_16_Jan_2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mangesh Tiwaskar 
Designation  Principal Investigator 
Affiliation  Shilpa Medical Centre 
Address  A1, Shilpa Medical Centre , Rainbow Apt, Opp Maratha Mandir Bank Avadoot Nagar , Dahisar

Mumbai
MAHARASHTRA
400068
India 
Phone    
Fax    
Email  tiwaskar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srirupa Das 
Designation  Director Medical Affairs 
Affiliation  Abbott India Ltd 
Address  Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E),Mumbai Mumbai MAHARASHTRA 4000051 India Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone    
Fax    
Email  srirupa.das@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Acharya 
Designation  Associate Director – Clinical Development & Pharmacovigilance 
Affiliation  Abbott India Ltd 
Address  Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E),Mumbai Mumbai MAHARASHTRA 4000051 India Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone    
Fax    
Email  shivani.acharya@abbott.com  
 
Source of Monetary or Material Support  
Abbott India Ltd 
 
Primary Sponsor  
Name  Abbott India Ltd 
Address  Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E),Mumbai Mumbai MAHARASHTRA 4000051 India Mumbai MAHARASHTRA 400051 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akhila Rao  Ashraya Clinic  Central Shopping, complex, Yelahanka new town, Bangalore
Bangalore
KARNATAKA 		 9449800493

akrao3@gmail.com 
Vikas Bhardwaj  Bhardwaj Ortho Centre  C-9 EAST, Baldev Park Parwana Rd, Baldev Park, Krishna Nagar, Delhi, 11005
East
DELHI 		 98684-39360

vikasdoc69@yahoo.co.in 
Rakesh Sharma  Dr Rakesh Sharma’s clinic  A/89, Block A, Subhadra Colony, Sarai Rohilla, New Delhi, Delhi 110035
North West
DELHI 		 9810134361

dr.rakesh@rediffmail.com 
Dr Mangesh Tiwaskar  Shilpa Medical Centre  A1,Shilpa Medical Centre, Rainbow Apt, Opp Maratha Mandir Bank Avadoot Nagar , Dahisar
Mumbai
MAHARASHTRA 		 9820067424

tiwaskar@gmail.com 
Dr SDI Ranjit   Swarnarani Clinic  837, 8th Main Road, 5th block, B E L Layout, Vidyaranyapura, Bengaluru, Karnataka 560097
Bangalore
KARNATAKA 		 94826643600

sdiranjit@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female patients aged ≥ 18 years
2. Patients newly diagnosed with vitamin D deficiency or insufficiency of known or
unknown origin.
3. Patients who are willing to provide written patient authorization
4. Patients with stable anti-hypertension treatment for last 2 months. In case of
Hypertension sub-group only.
5. Patients with stable anti-diabetes treatment for last 2 months. In case of Diabetes subgroup
only. 
 
ExclusionCriteria 
Details  1. Patients already on treatment for vitamin D deficiency/insufficiency
2. Female patients who are pregnant
3. Patients with a serum level of 25(OH)D > 30 ng/mL
4. Patients who are not willing to provide written patient authorization 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To understand the patient profile in terms of demographic and anthropometric measurements, exposure to sunlight, lifestyle pattern, and socioeconomic status
2. To determine the clinical characteristics in terms of clinical signs and symptoms at baseline and weeks 4 and 8  		 Week 4 and 8 
 
Secondary Outcome  
Outcome  TimePoints 
1.Type and number of comorbidities at baseline.
2. Proportion of patients who are prescribed with vitamin D supplements, including its formulation (as tablets/capsules, injections, or granules in sachets), dose, route, frequency, and duration at weeks 4 and 8
3. Change in 25(OH)D levels from baseline to weeks 4 and 8
4. Number and proportion of patients with adverse events (AEs)/serious AEs  		 Week 4 and 8 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   25/03/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Participant data collected during the trial after deidentification will be made available in the form of publication (text, tables, figures and appendices). Data will be available for anyone who wishes to access the publication. Additional information proposals should be directed to shivani.acharya@abbott.com 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a study to determine patient and disease profile in adult patients with Vitamin D deficiency.The study will enroll approximately 200 patients with vitamin D deficiency/insufficiency in approximately 10 sites. Clinical signs and symptoms, physical examinations at baseline and weeks 4 and 8 will be summarized using descriptive statistics. 
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