| CTRI Number |
CTRI/2025/11/096791 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Why some Women Do Not Improve with iron and folic acid treatment for anemia. |
|
Scientific Title of Study
|
Root cause analysis(RCA)of non-responders to Iron folic acid treatment among women of reproductive age(WRA)at community setting |
| 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 Neena Malhotra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences Delhi |
| Address |
Department of Obstetrics and Gynaecology Mother and Child block All India Institute of Medical Sciences Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
9891557707 |
| Fax |
|
| Email |
malhotraneenaaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neena Malhotra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences Delhi |
| Address |
Department of Obstetrics and Gynaecology Mother and Child block All India Institute of Medical Sciences Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
9891557707 |
| Fax |
|
| Email |
malhotraneenaaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neena Malhotra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences Delhi |
| Address |
Department of Obstetrics and Gynaecology Mother and Child block All India Institute of Medical Sciences Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
9891557707 |
| Fax |
|
| Email |
malhotraneenaaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research AIIMS Campus Ansari Nagar |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research AIIMS Campus Ansari Nagar |
| Type of Sponsor |
Research institution |
|
|
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 Neena Malhotra |
AIIMS Delhi |
Room no 724, Mother and child block Aiims NEW delhi
South West
DELHI |
9891557707
malhotraneenaaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Invasive hemoglobinometer |
we will compare the result of invasive hemoglobinometer with non invasive hemoglobinometer |
| Comparator Agent |
Non -invasive hemoglobinometer |
we will compare the result of invasive and non invasive hemoglobinometer |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
women of reproductive age group 15 to 45 years living in a community |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| various causes of non response IFA treatment filled on the questionnaire |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceptance and response of I.V. iron treatment |
3 years |
| Acceptance and response of IV Iron treatment |
3 years |
|
|
Target Sample Size
|
Total Sample Size="12000"
Sample Size from India="12000"
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)
|
01/01/2026 |
| 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="3"
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
|
Anemia is a serious health problem among women of reproductive age (15-45 years) in India. despite large scale programs like Anemia Mukt Bharat many women continue to suffer from anemia and nearly 30% do not improve even after taking iron and folic acid tablets. This project aims to understand the reasons behind such treatment failure. The study will conducted in ballabgarh, haryana and around 12000 women will be screened for anemia using both invasive and non invasive hemoglobin testing devices. those found anemic will receive standard treatment. after one month women who do not show improvement will undergo further tests to identify possible causes such as vitamin B12 or folic acid deficiency poor absorption of iron, hemoglobin disorders. The study will also explore whether non invasive hemoglobin testing is more acceptable in women and frontline health workers compared to the traditional invasive method. In case of severe anemia intravenous iron treatment will be offered and its effectiveness evaluated. The findings will help in identifying the root cause of non-response to IFA improving screening acceptability and guiding better treatment strategies. |