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CTRI Number  CTRI/2020/01/023035 [Registered on: 30/01/2020] Trial Registered Prospectively
Last Modified On: 19/09/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Iron Deficiency Anemia in Adolescent Girls 
Scientific Title of Study   Estimation of prevalence of anemia and coverage of adolescent anemia control programs among girls aged 15-19 years in Nagpur District, India 
Trial Acronym  IDA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsha Dhurde 
Designation  Fogarty Global Health Research Fellow 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Kinkine Kutir,
Opposite Hanuman Temple, Vasant Nagar, Nagpur 440022, M.S
Nagpur
MAHARASHTRA
440022
India 
Phone  917122249569  
Fax    
Email  varsha.lmrf@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Varsha Dhurde 
Designation  Fogarty Global Health Research Fellow 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Kinkine Kutir
Opposite Hanuman Temple, Vasant Nagar, Nagpur 440022, M.S
Nagpur
MAHARASHTRA
440022
India 
Phone  917122249569  
Fax    
Email  varsha.lmrf@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Varsha Dhurde 
Designation  Fogarty Global Health Research Fellow 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Kinkine Kutir,
Opposite Hanuman Temple, Vasant Nagar, Nagpur 440022, M.S
Nagpur
MAHARASHTRA
440022
India 
Phone  917122249569  
Fax    
Email  varsha.lmrf@gmail.com  
 
Source of Monetary or Material Support  
HBNU Fogarty Global Health Consortium Department of Global Health and Population Harvard School of Public Health, 665 Huntington Avenue, Boston, MA 02115 
 
Primary Sponsor  
Name  Fogarty International National Institute Of Health 
Address  HBNU Fogarty Global Health Consortium Department of Global Health and Population Harvard School of Public Health  
Type of Sponsor  Other [Fellowship grant] 
 
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 
Varsha Dhurde  Primary Health Centres of Nagpur Rural region  Primary Health Center Nagardhan, Primary Health Center Mansar, Primary Health Center Salwa and Primary Health Center Kondhali
Nagpur
MAHARASHTRA 
917122249569

varsha.lmrf@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lata Medical Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screening for anemia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  Non pregnant girls residing in study clusters will be selected 
 
ExclusionCriteria 
Details  Pregnant, non resident girls and those who received Blood transfusion 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of anemia among girls  At age 15yrs,
At age 16 years
At age 17 years
At age 18yrs
At age 19 years 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2020 
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   Publications will be done after the completion of the study 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background: Anemia among Indian adolescent girls (15-19 years) is a major issue affecting 55.8% of the population. It not only impacts growth velocity during adolescence but also increases risk for adverse maternal and fetal outcomes.  In view of achieving World Health Assembly’s Global Nutrition Target 50% reduction in anemia it is imperative to focus on anemia among adolescent girls.  Objective: The study aims to assess the prevalence of anemia among girls 15-19 years and the coverage of existing adolescent anemia control programs in the rural and peri-urban areas around Nagpur district, Maharashtra, India.  Methods: A community based cross sectional survey would be done and randomly 250 girls would be chosen.  Data would be collected using pre-designed, pre-tested semi structured schedule. Data on anthropometric, blood parameters would be collected using standard methods. Standard classification by World Health Organization would be used for classifying anemia. Results: Hemoglobin would be treated as continuous variable. Data will be entered and analyzed in STATA software (version 13.1). Univariate and multivariate regression models would be used to explore the relationship between anemia control program exposure variables and risk of anemia. Conclusion: The present research study would give an estimate of anemia among adolescent girls from peri-urban and rural areas of Nagpur district. The findings of this study would serve as essential pilot data for developing a nutrition intervention targeting adolescent women in rural and peri-urban area.

 
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