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
|
|
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
|
|
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. |