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CTRI Number  CTRI/2021/09/036725 [Registered on: 22/09/2021] Trial Registered Prospectively
Last Modified On: 21/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Identify blood iron level and its any association with heart problem  
Scientific Title of Study   To study the correlation of iron status and cardiovascular risk score in sanitation workers at a Tertiary care center 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varsha Yadav 
Designation  Resident 
Affiliation  RUHS-CMS 
Address  Department of Biochemistry RUHS-CMS Pratap Nagar Jaipur RAJASTHAN

Jaipur
RAJASTHAN
302033
India 
Phone  9975279802  
Fax    
Email  yadavvarsha082@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr sonali sharma 
Designation  professor and Head of department 
Affiliation  RUHS-CMS 
Address  Department of biochemistry RUHS-CMS Pratap Nagar Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  9414314678  
Fax    
Email  sonalisharma14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr sonali sharma 
Designation  professor and Head of department 
Affiliation  RUHS-CMS 
Address  Department of biochemistry RUHS-CMS Pratap Nagar Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  9414314678  
Fax    
Email  sonalisharma14@gmail.com  
 
Source of Monetary or Material Support  
department of biochemistry RUHS-CMS associated RDBP Jaipuriya hospital 
 
Primary Sponsor  
Name  Dr varsha yadav 
Address  RUHS-CMS Pratap Nagar,jaipur 
Type of Sponsor  Other [self] 
 
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 varsha yadav  Department of Biochemistry, RUHS-CMS and associated hospital   Central lab department of biochemistry, RUHS Jaipur Rajasthan
Jaipur
RAJASTHAN 		 9975279802

yadavvarsha082@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RUHS-CMS ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Unspecified 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  •sanitation workers of age group between 18 to 50 years of either gender in RUHS Medical College and RDBP Jaipuria Hospital, associated hospital of RUHS College of Medical sciences, Jaipur
•willing to participate.
 
 
ExclusionCriteria 
Details  •chronic disease of heart, liver, kidney, gastrointestinal tract
•pregnancy,
•lactation
•neurological & psychiatric disorders
•infectious diseases like hepatitis, HIV
• history of blood transfusion
• on iron therapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the iron status in sanitation workers and its correlation with iron cardiovascular risk score.


 		 1 year and 6 month

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess dietary factors contributing to iron deficiency anemia in sanitation workers  1 year and 6 month 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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)   10/10/2021 
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="6"
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   Iron deficiency is the most prevalent global nutrient deficiency recognized by the World Health Organization (WHO) that affects both developing and developed countries with serious consequences for human health. The prevalence of iron deficiency is highest in developing countries and its causes are multifactorial including age, sex and physiological, pathological, dietary and socioeconomic conditions .Previous reports have shown that there is definite correlation between socioeconomic status and anemia .Micronutrient deficiency is also a major health challenge in sanitation workers. Sanitation workers of hospitals provides invaluable service and serve vital to the proper functioning of the sanitation system that underpin hospital functioning. The plight of urban sanitation worker is often invisible and delivery of health services to sanitation worker is often overlooked. Little research has been focused on the health status and there is a dearth of information about health of sanitation workers. Establishing the relationship between measures of iron status and cardiovascular (CV) risk score will give an indication of health status and future risk of CVD risk in sanitation workers. In view of this scenario present study is aimed to evaluate the measures of iron status (ferritin, serum iron and hemoglobin concentrations, total iron-binding capacity and percentage transferrin saturation) and risk of developing CVD in these sanitation workers. By assessing measures of iron status, cardiovascular risk score will be determined in sanitation workers. So, we can provide knowledge about nutrition and balanced diet to improve nutritional status thus safeguarding health and help in reduction the risk of CVD in these sanitation workers. 
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