| 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
|
|
|
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
|
|
|
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.
|