| CTRI Number |
CTRI/2025/10/096237 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
19/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of conventional iron vs liposomal iron preparation for treating iron deficiency anemia in pregnancy. |
|
Scientific Title of Study
|
Effectiveness and tolerability of liposomal iron compared to conventional iron supplementation in treating iron deficiency anemia in antenatal women a randomized controlled trial |
| 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 SAHELI ROY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Departments of Pharmacology and Obstetrics and Gynecology, IPGMER and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9775625465 |
| Fax |
|
| Email |
sahali.roy1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AVIJIT HAZRA |
| Designation |
PROFESSOR |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Pharmacology, IPGMER and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831188172 |
| Fax |
|
| Email |
blowfans@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR AVIJIT HAZRA |
| Designation |
PROFESSOR |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Pharmacology, IPGMER and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831188172 |
| Fax |
|
| Email |
blowfans@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology, IPGMER and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology Institute of Post Graduate Medical Education And Research |
| Address |
Institute of Post Graduate Medical Education And Research.
244 A.J.C Bose Road Kolkata 700020 |
| Type of Sponsor |
Government medical college |
|
|
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 SAHELI ROY |
IPGMER and SSKM Hospital |
OPD ,
Room number 7 ,
Department of Obstetrics and Gynaecology
Kolkata
WEST BENGAL |
9775625465
sahali.roy1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional iron (ferrous sulfate - 60 mg elemental iron per tablet) [Govt. of
West Bengal hospital supply] |
Oral ferrous sulfate is a common and generally safe treatment for iron deficiency anemia (IDA) during pregnancy, but its effectiveness can be limited by poor gastrointestinal (GI) tolerability. The standard dose is 60 mg of ferrous iron daily, starting around week 12 of pregnancy. |
| Intervention |
Liposomal iron – 29 mg elemental iron per tablet |
Liposomal iron is a form of oral iron supplement where the iron is encapsulated within liposomes. This liposomal delivery system protects the iron from interacting directly with the stomach lining, resulting in possibly higher absorption, better bioavailability, and a lower incidence of gastrointestinal side effects like nausea, constipation, and irritation, compared to conventional iron supplements. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women aged at least 18 years.
Gestational age at least 14 weeks (second trimester).
Diagnosed with iron deficiency anemia (Hb 7.0 to 10.5 g/dL with other parameters
suggestive of iron deficiency)
Willing to provide written informed consent and adhere to study. |
|
| ExclusionCriteria |
| Details |
Severe anemia (Hb less than 7 g/dL)
Requirement of parenteral iron.
History of hookworm infestation or chronic bleeding from any source.
Known hemoglobinopathies (For example thalassemia, sickle cell anemia).
Gastrointestinal disorders affecting iron absorption.
History of allergy to oral iron supplements.
Co-existing chronic illnesses (For example chronic kidney disease, malignancy, chronic liver
disease) likely to affect response to oral iron therapy).
Received parenteral iron therapy within last 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in hemoglobin by 2 gm/ dl after treatment |
Participants will be followed up at 4, 8, and 12 weeks post enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in serum iron, total iron binding capacity, transferrin saturation.
Changes in PCV, RBC indices (MCV, MCH, MCHC) and peripheral red cell morphology. |
Participants will be followed up at 12 weeks post enrolment |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate whether liposomal iron is a better tolerated and equally or more effective alternative to conventional ferrous sulfate in pregnant women with iron deficiency anemia. Participants will be followed up at 4 8 and 12 weeks to assess changes in hemoglobin, packed cell volume, red cell indices, serum iron ferritin and transferrin saturation. Gastrointestinal tolerability will be measured using symptom assessment and adverse event monitoring. The expected outcome is to generate India specific evidence on the role of liposomal iron in improving outcomes in antenatal anemia management. |