| CTRI Number |
CTRI/2019/08/020984 [Registered on: 30/08/2019] Trial Registered Prospectively |
| Last Modified On: |
28/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
In between rural and urban population going to compare Vitamin B12 status and its knowledge |
|
Scientific Title of Study
|
Comparison of knowledge, attitude and practice about vitamin B12 and vitamin B12 status between reproductive women from rural and urban population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwini H |
| Designation |
Student |
| Affiliation |
MCHP, MAHE |
| Address |
Department of Medical Laboratory Technology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449354075 |
| Fax |
|
| Email |
ashwinihgams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwini H |
| Designation |
Student |
| Affiliation |
MCHP, MAHE |
| Address |
Department of Medical Laboratory Technology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449354075 |
| Fax |
|
| Email |
ashwinihgams@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saritha Kamath U |
| Designation |
Head of Department of MLT |
| Affiliation |
MCHP, MAHE |
| Address |
Department of Medical Laboratory Technology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844344459 |
| Fax |
|
| Email |
saritha.kamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Institutional seed money,
Department of MLT, MCHP, MAHE,Manipal |
|
|
Primary Sponsor
|
| Name |
Institutional seed money |
| Address |
Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Saritha Kamath U |
Manipal College of Health Professions |
Department of Medical Laboratory Technology,Biochemistry section,room number 418, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA |
9844344459
saritha.kamath@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants who come for routine checkup
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
knowledge, attitude and practice about vitamin B12 in rural and urban population†|
Through questionnaires, Knowledge Attitude and Practice screening are done |
| Comparator Agent |
vitamin B12 status between reproductive women from rural and urban population†|
Blood test analysis of Vitamin B12 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Group 1: Women’s of reproductive age from rural population.
Group 2: Women’s of reproductive age from urban population.
|
|
| ExclusionCriteria |
| Details |
For both group: women’s who are on vitamin B12 supplementation, antibiotic therapy, inflammatory diseases, with any malignancy, thyroid problem, diabetes mellitus, and mental disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The difference in Knowledge, attitude and practice between rural and urban reproductive women population |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparision of Vitamin B12 status between rural and urban reproductive women |
1 year |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
01/10/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study will be started after getting approval from Institutional research committee and Institutional ethical committee Manipal, Manipal Academy of Higher Education and CTRI registration.Permission from Kasturba Medical College, Manipal will be taken. Reproductive aged women visits hospital for routine checkup. If the reproductive age women is given with any blood investigation forms we will be asking their informed consent to use the left over serum samples or to collect additional 2 ml plain sample and to collect urine sample for homocysteine and MMA Details regarding demography, education, food habit, supplementation will be collected as per proforma. Complete blood picture result will be collected from the medical records after obtaining permission from Medical Superintendent. |