| CTRI Number |
CTRI/2023/03/050198 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
26/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study anaemia in elderly population and its possible causes and complications |
|
Scientific Title of Study
|
A study to assess the prevalence of anaemia and its associated factors among elderly population residing in a rural community of Udupi Taluk - A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rishi S Narayanan |
| Designation |
1st year Postgraduate |
| Affiliation |
Kasturba Medical College, Manipal, MAHE Manipal |
| Address |
Department of Community Medicine
Kasturba Medical College, Manipal
MAHE, Manipal
Madhav Nagar, Manipal
Udupi District
Karnataka -576104
Udupi
KARNATAKA
576104
India |
| Phone |
9035239430 |
| Fax |
|
| Email |
rishi.narayanan@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena G Kamath |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE Manipal |
| Address |
Department of Community Medicine
Kasturba Medical College, Manipal
MAHE, Manipal
Madhav Nagar, Manipal
Udupi District
Karnataka -576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845304647 |
| Fax |
|
| Email |
veenak@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rishi S Narayanan |
| Designation |
1st year Postgraduate |
| Affiliation |
Kasturba Medical College, Manipal, MAHE Manipal |
| Address |
Department of Community Medicine
Kasturba Medical College, Manipal
MAHE, Manipal
Madhav Nagar, Manipal
Udupi District
Karnataka -576104
Udupi
KARNATAKA
576104
India |
| Phone |
9035239430 |
| Fax |
|
| Email |
rishi.narayanan@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Postgraduate Research Grant, Kasturba Medical College, Manipal, MAHE Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal, MAHE Manipal |
| Address |
Madhav Nagar, Manipal
Udupi District
Karnataka - 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Rishi S Narayanan |
Kasturba Medical College, Manipal, MAHE Manipal |
Department of Community Medicine,
Tiger Circle Road, Madhav Nagar, Manipal - 576104
Udupi
KARNATAKA |
9035239430
rishi.narayanan@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Persons aged 60 years or more and resident of the field practice area of the Department of Community Medicine, Kasturba Medical College, Manipal, MAHE Manipal |
|
| ExclusionCriteria |
| Details |
Elderly persons who are: 
1. unable to comprehend or give answers  
2. not willing to give consent for the study  |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Prevalence of anaemia in elderly
2. Identifying the risk factors of anaemia in elderly |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="408"
Sample Size from India="408"
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)
|
01/03/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
​This study will be undertaken to estimate the prevalence of anaemia in the elderly and assess the risk factors associated with it. Anaemia among elderly is a major public health problem as identified by many studies in India and other countries. ​Diagnosis of anaemia is often overlooked during clinical evaluation of the elderly. ​ Early identification of anaemia can help in appropriate management as well as prevent the resultant morbidity, complications and improve the quality of life of elderly. ​ No studies have been carried out in Udupi district with regard to this major concern. ​ Hence a community-based study has been planned to estimate the prevalence of anaemia among elderly and its associated factors.
|