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CTRI Number  CTRI/2015/03/005620 [Registered on: 10/03/2015] Trial Registered Retrospectively
Last Modified On: 27/06/2016
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Spectrum of Manifestation of Vitamin B 12 Deficiency  
Scientific Title of Study   Spectrum of presentation of Vitamin B 12 deficiency in adult patients in a tertiary care hospital  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meenakshi 
Designation  DNB Resident 
Affiliation  Max Super Speciality Hospital 
Address  C-65 Defence Colony New Delhi
1 Press Enclave Road Saket New Delhi 110017
South
DELHI
110024
India 
Phone  9810594714  
Fax    
Email  meenakshidr1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Meenakshi 
Designation  DNB Resident 
Affiliation  Max Super Speciality Hospital 
Address  C-65 Defence Colony New Delhi
1 Press Enclave Road Saket New Delhi 110017
South
DELHI
110024
India 
Phone  9810594714  
Fax    
Email  meenakshidr1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monica Mahajan 
Designation  Senior Consultant Internal Medicine 
Affiliation  Max Hospital 
Address  Max Super Speciality Hospital 1 Press Enclave Road New Delhi
Max Super Speciality Hospital 1 Press Enclave Road New Delhi
South
DELHI
110017
India 
Phone    
Fax    
Email  mmahajan@maxhealthcare.com  
 
Source of Monetary or Material Support  
Max Super Speciality Hospital, 1 Press Enclave Road, Saket, New Delhi 110017 
 
Primary Sponsor  
Name  Max Super Speciality Hospital 
Address  1 Press Enclave Road Saket New Delhi 110017 
Type of Sponsor  Private hospital/clinic 
 
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 Meenakshi  Max Super Speciality Hospital  Dept of Family Medicine, Service Floor,1 Press Enclave Road Saket, New Delhi 110017
South
DELHI 
9810594714

meenakshidr1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Max Healthcare Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B 12 Deficient,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ALL ADULTS 18 YEARS AND ABOVE 
 
ExclusionCriteria 
Details  1.Patients who refuse to participate in the study;
2.Patients who have taken Vitamin B12 supplementation (even one dose)in the past 3 months
3.Patients who have folate deficiency

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To elicit the spectrum of manifestations of the Vitamin B12 deficiency in an adult population in
Max Hospital, Saket, New Delhi.
 
7/5/2014-7/5/2015 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objectives-
1. To correlate Demographic data including age, gender, socio-economic data with Vitamin B12 deficiency
2. To study the hematological complications of Vitamin B12 deficiency
3. To study the neurological complications of Vitamin B12 deficiency
4. To study other complications of Vitamin B12 deficiency

 
7/5/2014-7/5/2015 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/05/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Will publish in national and international journal 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

We conducted a study on ‘The clinical spectrum of presentation of Vitamin B12 deficiency in adult patients in a tertiary care hospital’. This was a descriptive cross sectional study of 12 months starting from May, 2014 to May, 2015 conducted in Max Super Specialty Hospital, Saket, and New Delhi. This study was done on the basis of laboratory values of serum Vitamin B12 <145 pg/ml which was requested by the physician on the basis of their clinical suspicion. The study is unique to the tertiary care set up in India where studies based on laboratory results have been published however not on the clinical spectrum of the deficiency.

The following observations were made

1.      There was a varied presentation of the deficiency from haematological, neurological, gastrointestinal, rheumatological, neurologica, cardiological, endocrine, respiratory disorders to association with infections

2.      Vitamin B12 deficiency was found more prevalent in the elderly age group.

3.      No significant correlation was found with socioeconomic  and educational status or gender.

4.      Vitamin B12 deficiency was found in 2% people who were lactose intolerant and the Vitamin B12 levels was lesser in people who did not take milk products.

5.      Vitamin B12 levels were found lesser in subjects who  consumed alcohol and who previously consumed  alcohol but had left now.

6.      Vitamin B12 levels were found lesser in smokers and past smokers.

7.      There was a high association of combined deficiency of Vitamin B12 and Vitamin D3

8.      There was a good correlation of cognitive impairment and generalised weakness and reduced stamina.

9.      Metformin usage showed lower Vitamin B12 levels in Type 11 Diabetics.

 

 




 
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