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CTRI Number  CTRI/2024/02/062530 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 05/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of micronutrient deficiencies in young women in Bangalore. 
Scientific Title of Study   A comprehensive assessment of anaemia and micronutrient deficiencies in women of reproductive age (WRA) in lower socio-economic communities within Rajendra Nagar and L R Nagar, Bangalore 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prashanth Thankachan 
Designation  Associate Professor 
Affiliation  St. John’s Research Institute 
Address  Division of Nutrition, St John’s Research Institute, St John’s National Academy of Health Sciences, Sarjapura Road

Bangalore
KARNATAKA
560034
India 
Phone  9886006166  
Fax    
Email  prashanth.t@sjri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashanth Thankachan 
Designation  Associate Professor 
Affiliation  St. John’s Research Institute 
Address  Division of Nutrition, St John’s Research Institute, St John’s National Academy of Health Sciences, Sarjapura Road

Bangalore
KARNATAKA
560034
India 
Phone  9886006166  
Fax    
Email  prashanth.t@sjri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Prashanth Thankachan 
Designation  Associate Professor 
Affiliation  St. John’s Research Institute 
Address  Division of Nutrition, St John’s Research Institute, St John’s National Academy of Health Sciences, Sarjapura Road

Bangalore
KARNATAKA
560034
India 
Phone  9886006166  
Fax    
Email  prashanth.t@sjri.res.in  
 
Source of Monetary or Material Support  
St Johns Research Institute 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Prashanth Thankachan  St Johns Research Institute  Division of Nutrition, 1st Floor, St Johns Research Institute,St Johns National Academy of Health Sciences. Sarjapura Road
Bangalore
KARNATAKA 		 08049467000

Prashanth.t@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, St Johns Medical college and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Women of reproductive age 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  1. Women in their reproductive age; between 18 and 49 years.
2. Those willing to participate and provide informed consent to the study protocol
3. Women who consent to all of the study procedures.
4.Pregnant or lactating women who are willing to participate and provide informed consent according to the study protocol will be included as well
 
 
ExclusionCriteria 
Details  Women who are severely anaemic and with underlying chronic health conditions, under medications or diagnosed with known medical conditions affecting iron metabolism will be excluded from the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will help to assess the prevalence of anaemia, iron deficiency and iron deficiency anaemia in women of reproductive age from the lower socio-economic strata of the population from the Rajendra Nagar and L. R Nagar areas of Bangalore.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the micronutrient status of WRA emphasizing vitamin B12, vitamin D, & folate levels along with dietary intake from the lower-economic communities residing in Rajendra Nagar & L R Nagar  Baseline 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   15/02/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In the global pursuit of improving maternal and child health, the prevalence of anaemia and micronutrient deficiencies among women of reproductive age has emerged as a critical public health concern. Anaemia, characterized by a deficiency in red blood cells or haemoglobin, often coexists with insufficient intake of essential vitamins and minerals, collectively known as micronutrients. Women of reproductive age, especially during pregnancy and lactation, require adequate nutrition to ensure their well-being and the healthy development of their offspring. Anaemia and micronutrient deficiencies, encompassing vital nutrients such as iron, vitamin B12, vitamin D, and folate, significantly impact the well-being of women during their reproductive years. This study seeks to delve deep into the prevalence, causes, and consequences of anaemia and micronutrient deficiencies among women of reproductive age, in Bangalore’s Rajendra Nagar and L R Nagar with a focus on exploring regional variances, socioeconomic determinants, and dietary patterns that contribute to these nutritional challenges.

This study embarks on a comprehensive investigation in the urban slums of Rajendra Nagar and L R Nagar, Bangalore, focusing on WRA to address two primary objectives. Firstly, it seeks to assess the prevalence of anaemia, iron deficiency, and iron deficiency anaemia, recognizing their profound implications on the health of women during their childbearing years. Secondly, the study aims to evaluate the micronutrient status of these women, with a particular emphasis on vitamin B12, vitamin D, and folate levels, recognizing that these essential micronutrients play a pivotal role in maternal and child health. By undertaking this multifaceted approach, the research aspires to offer a holistic understanding of the nutritional challenges faced by women in lower-economic communities, thereby contributing valuable insights that can guide targeted interventions and healthcare policies tailored to the unique needs of this vulnerable population in Rajendra Nagar and L R Nagar.

 
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