AnemiaPhase 2/3NCT07648628
Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Post Partum Iron Deficiency Anaemia
A Phase 2/3 study testing Ferric Carboxymaltose (FCM) in people with Anemia and Anemia, Postpartum, run by ESI-PGIMSR, Basaidarapur at 1 site in India.
Trial summary
The aim of this open label, interventional, randomized controlled clinical trial is to compare the efficacy and safety of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anaemia in postnatal women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anemia, Anemia, Postpartum, Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Ferric Carboxymaltose (FCM)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2024to 16 Aug 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postnatal women within 10 days of delivery.
- Hb should be >7 gm/dl and ≤10 gm.
- Peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index >13.
Who cannot join
- 1. Puerperal pyrexia. 2. Known drug allergy or intolerance to iron therapy. 3. History of chronic medical illness. 4. Known cases of Thalassemia 5. Received other intervention for management of anaemia such as blood transfusion in last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Treatment of Post Partum Iron Deficiency Anaemia
The aim of this open label, interventional, randomized controlled clinical trial is to compare the efficacy and safety of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anaemia in postnatal women. Inclusion criteria:women within 10 days of delivery, Hb >7 gm/dl and ≤10 gm and peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index >13.
Primary outcome measures-rise in Hb from baseline to 4 and 6 weeks Secondary outcome measures-Percentage of patients achieving Hb >11 g/dl at 4 and 6 weeks.
Read more
Percentage of patients achieving Hb rise >3 g/dl from baseline at 4 and 6 weeks Change in red cell indices and peripheral smear from baseline to 6 weeks Side effects profile of injectable Ferric carboxymaltose injection and oral iron.
Researcher compares the efficacy and safety of ferric carboxymaltose with Oral iron in post partum iron deficiency anaemia Participant's detailed history, general physical and systemic examination was performed. CBC with red cell indices, reticulocyte counts, peripheral smear examination, serum Iron, Ferritin, Transferrin, TIBC levels and LFT were done.
Subjects were randomized in a 1:1 ratio into two groups: Group I (n=100) received intravenous ferric carboxymaltose and Group II (n=100) received oral ferrous Fumarate twice a day for 6 weeks.
All subjects were followed at 4 and 6 weeks. Repeat Hb estimation was done at 4 and 6 weeks while RBC indices and serum iron parameters were repeated at 6 weeks. Adverse effects were recorded.
- Conditions
- Anemia, Anemia, Postpartum, Iron Deficiency Anemia of Pregnancy, Iron Deficiency Anemia Treatment, FCM
- Being tested
- Ferric Carboxymaltose (FCM)
- Keywords
- Post partum iron deficiency anemia, Ferric carboxymaltose, Oral iron treatment, Post partum anaemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose (FCM)Drug
FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes. FCM was repeated weekly up to calculated dose or maximum of 2500mg.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Ferric carboxymaltose (FCM) | Experimental | FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes During infusion, subject was kept under strict observation. FCM was repeated weekly up to calculated dose or maximum of 2500mg.
Total dose of IV FCM was calculated by Ganzoni formula: - Total dose of iron = body weight (in kg) x (14-actual Hb) x 2.4 + 500 where, 14 is target Hb (g/dl), 2.4 unitless conversion constant, 500 is target iron store in mg Receives: Drug: Ferric Carboxymaltose (FCM) |
| Group II : Oral Iron | Active comparator | Second group of subjects were instructed to take oral iron (ferrous fumarate tablet containing 112 mg elemental iron) 2 times daily 1 hour before meals for 6 weeks. Receives: Drug: Ferric Carboxymaltose (FCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean increase in haemoglobin at 4 weeks and 6 weeks in Group I versus Group II
The mean change in haemoglobin was measured at 4 weeks and 6 weeks post intervention in parenteral and oral group.
Measured: Haemoglobin measurement at baseline, 4 week post treatment and 6 week post FCM intervention or adequate oral treatment
Secondary outcomes (5)
Anaemia correction(Hb >11 gm/dl), from baseline at 4 and 6 weeks in group I versus Group II
Percentage of women in the parenteral group as compared to oral group who achieved correction of anaemia i.e. Hb >11gm/dl at 4 and 6 weeks post intervention.
Measured: Anaemia correction (Hb>11gm/dl) at 4 week and 6 week post FCM intervention or adequate oral treatment
Haemoglobin (Hb) rise> 3gm/dl from baseline at 4 and 6 weeks in group I versus Group II
Women in the parenteral group as compared to oral group who achieved Haemoglobin rise of >3gm/dl at 4 and 6 weeks post intervention.
Measured: Hb rise> 3 gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
Haemoglobin (Hb) rise>2gm from baseline at 4 and 6 weeks in group I versus Group II
Women in the parenteral group as compared to oral group who achieved haemoglobin (Hb) rise>2gm from baseline at 4 week and 6 week post intervention.
Measured: Hb rise>2gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
Change in red cell indices and peripheral smear from baseline to 6 weeks
To record changes in all the haematological parameters from baseline to 6 weeks post intervention both parenteral and oral groups.
Measured: Change in red cell indices and peripheral smear at baseline and 6 week post FCM intervention or adequate oral treatment
Side effects profile for participants of Group I and II
To record the side effect profile in participants of parenteral and oral group in order to determine safety of the intervention upto 6 weeks post intervention.
Measured: Side effects observed in participants receiving Group I and Group II treatment upto 6 weeks post intervention..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Mar 2024
- Primary completion5 Jul 2025
- Study completion16 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESI-PGIMSR, Basaidarapur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shreya Mahajan, ESI-PGIMSR, Basaidarapur
- Investigators
- Shreya Mahajan, MBBS, Principal investigator, Post graduate resident, Department of OBG, ESI-PGIMSR, Basaidarapur,Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648628
- Sponsor's protocol ID
- ESIPGIMSR-IEC/2024031
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Treatment of Post Partum Iron Deficiency Anaemia
- ClinicalTrials.gov ID
- NCT07648628
- Acronym / sponsor ID
- ESIPGIMSR-IEC/2024031
- Conditions
- Anemia, Anemia, Postpartum, Iron Deficiency Anemia of Pregnancy, Iron Deficiency Anemia Treatment, FCM
- Keywords
- Post partum iron deficiency anemia, Ferric carboxymaltose, Oral iron treatment, Post partum anaemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ESI-PGIMSR, BasaidarapurUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this open label, interventional, randomized controlled clinical trial is to compare the efficacy and safety of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anaemia in postnatal women. Inclusion criteria:women within 10 days of delivery, Hb >7 gm/dl and ≤10 gm and peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index >13.
Primary outcome measures-rise in Hb from baseline to 4 and 6 weeks Secondary outcome measures-Percentage of patients achieving Hb >11 g/dl at 4 and 6 weeks.
Percentage of patients achieving Hb rise >3 g/dl from baseline at 4 and 6 weeks Change in red cell indices and peripheral smear from baseline to 6 weeks Side effects profile of injectable Ferric carboxymaltose injection and oral iron.
Researcher compares the efficacy and safety of ferric carboxymaltose with Oral iron in post partum iron deficiency anaemia Participant's detailed history, general physical and systemic examination was performed. CBC with red cell indices, reticulocyte counts, peripheral smear examination, serum Iron, Ferritin, Transferrin, TIBC levels and LFT were done.
Subjects were randomized in a 1:1 ratio into two groups: Group I (n=100) received intravenous ferric carboxymaltose and Group II (n=100) received oral ferrous Fumarate twice a day for 6 weeks.
All subjects were followed at 4 and 6 weeks. Repeat Hb estimation was done at 4 and 6 weeks while RBC indices and serum iron parameters were repeated at 6 weeks. Adverse effects were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Ferric carboxymaltose (FCM) | Experimental | Drug: Ferric Carboxymaltose (FCM)FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes During infusion, subject was kept under strict observation. FCM was repeated weekly up to calculated dose or maximum of 2500mg. Total dose of IV FCM was calculated by Ganzoni formula: - Total dose of iron = body weight (in kg) x (14-actual Hb) x 2.4 + 500 where, 14 is target Hb (g/dl), 2.4 unitless conversion constant, 500 is target iron store in mg |
| Group II : Oral Iron | Active comparator | Drug: Ferric Carboxymaltose (FCM)Second group of subjects were instructed to take oral iron (ferrous fumarate tablet containing 112 mg elemental iron) 2 times daily 1 hour before meals for 6 weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Postnatal women within 10 days of delivery.
- Hb should be >7 gm/dl and ≤10 gm.
- Peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index >13.
Key exclusion criteria (1 listed)
- 1. Puerperal pyrexia. 2. Known drug allergy or intolerance to iron therapy. 3. History of chronic medical illness. 4. Known cases of Thalassemia 5. Received other intervention for management of anaemia such as blood transfusion in last three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose (FCM)FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes. FCM was repeated weekly up to calculated dose or maximum of 2500mg. | Drug | Group I: Ferric carboxymaltose (FCM), Group II : Oral Iron |
Primary outcome
Mean increase in haemoglobin at 4 weeks and 6 weeks in Group I versus Group II
Time frame: Haemoglobin measurement at baseline, 4 week post treatment and 6 week post FCM intervention or adequate oral treatment
The mean change in haemoglobin was measured at 4 weeks and 6 weeks post intervention in parenteral and oral group.
5 secondary outcomes
Anaemia correction(Hb >11 gm/dl), from baseline at 4 and 6 weeks in group I versus Group II
Time frame: Anaemia correction (Hb>11gm/dl) at 4 week and 6 week post FCM intervention or adequate oral treatment
Haemoglobin (Hb) rise> 3gm/dl from baseline at 4 and 6 weeks in group I versus Group II
Time frame: Hb rise> 3 gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
Haemoglobin (Hb) rise>2gm from baseline at 4 and 6 weeks in group I versus Group II
Time frame: Hb rise>2gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
Change in red cell indices and peripheral smear from baseline to 6 weeks
Time frame: Change in red cell indices and peripheral smear at baseline and 6 week post FCM intervention or adequate oral treatment
Side effects profile for participants of Group I and II
Time frame: Side effects observed in participants receiving Group I and Group II treatment upto 6 weeks post intervention..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shreya Mahajan, MBBS principal investigator
Post graduate resident, Department of OBG, ESI-PGIMSR, Basaidarapur,Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ferric Carboxymaltose (FCM) in people with Anemia and Anemia, Postpartum, run by ESI-PGIMSR, Basaidarapur at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean increase in haemoglobin at 4 weeks and 6 weeks in Group I versus Group II (time frame: Haemoglobin measurement at baseline, 4 week post treatment and 6 week post FCM intervention or adequate oral treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.