Iron Deficiency Anemia (IDA)Phase 4NCT06911034
Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women
A Phase 4 study testing Iron Carboxymaltose and Iron Sucrose Injection in people with Iron Deficiency Anemia (IDA) and Pregnancy, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women. The main question it aimed to answer was: Is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Iron Deficiency Anemia (IDA), Pregnancy
- What is being tested?
- Iron Carboxymaltose and Iron Sucrose Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 30 Sep 2024
- Phase
- Phase 4
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 28-34 weeks of gestation
- Iron deficiency anemia (IDA): IDA will be labelled if Hemoglobin is <10 gm% and serum Ferritin < 30 ng/ml.
Who cannot join
- Hepatitis (serum transaminases more than 1.5 times the upper limit of normal) and HIV infection
- serum creatinine level of more than 2.0 mg/dL
- history of allergic reaction to intravenous iron infusion
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Cmh Multan Institute of Medical Sciences
Multan, Punjab Province, 60000
About this study
Official title: Comparison of Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anemia in Pregnant Women
This clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women.
The main question it aimed to answer was:
Read more
Is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women.
Sixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments.
- Participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min.
- Participants in iron sucrose group were administered an infusion of 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.
Read the detailed description
The study was conducted after the ethics review committee approval. A total of 60 pregnant women presenting to the department of Obstetrics and Gynecology and fulfilling the eligibility criteria were enrolled in the study after informed consent. Patient's characteristics including age, parity, area of residence, educational status, socioeconomic status and baseline Hb were recorded. All women were administered anthelminthic therapy with tablet mebendazole 100 mg twice daily for three days and given 5 mg Folic acid once daily. Patients were be randomly assigned to group A \& B.
Patients in group A were treated with intravenous ferrous carboxymaltose and group B were given intravenous iron sucrose complex. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.
- Conditions
- Iron Deficiency Anemia (IDA), Pregnancy
- Being tested
- Iron Carboxymaltose, Iron Sucrose Injection
- Keywords
- Iron deficiency anemia, Pregnancy, Ferric carboxymaltose, Iron sucrose
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron CarboxymaltoseDrug
Also called Ferrous Carboxymaltose
In ferrous carboxymaltose treatment maximum dose per sitting was 1000 mg, diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.
Iron Sucrose InjectionDrug
Also called sucroferric oxyhydroxide, Iron saccharate
Iron sucrose infusion was administered as 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.
| Study group | Role | What they receive |
|---|---|---|
| Carboxymaltose | Experimental | Intravenous infusion Receives: Drug: Iron Carboxymaltose |
| Sucrose | Active comparator | Intravenous infusion Receives: Drug: Iron Sucrose Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin
Rise in hemoglobin (g/dl) will be calculated by subtracting post treatment hemoglobin from pre-treatment hemoglobin
Measured: After three weeks of completing parenteral iron therapy
Secondary outcomes (1)
Ferritin levels
Post treatment ferritin levels will be done
Measured: Three weeks after completion of parenteral iron therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Feb 2024
- Primary completion31 Jul 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia (IDA)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Multan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kiran Saleem, CMH Multan Institute of Medical Sciences
- Investigators
- Nidda Ya Consultant, FCPS, Study chair, CMH Multan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911034
- Sponsor's protocol ID
- U1111-1319-2291
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD can compromise patient privacy, even if identifying details are removed. Sensitive medical information could potentially be re-identified, violating ethical guidelines.
Publications
Bharadwaj MK, Patrikar S, Singh Y. Comparative analysis of injection ferric carboxymaltose vs iron sucrose for treatment of iron-deficiency anemia in pregnancy: systematic review and meta-analysis. J South Asian Fed Obstet Gynaecol. 2023;15(5):629-36.
Comparison of ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia in pregnancy at tertiary care centre, Western India. Int J Reprod Contracept Obstet Gynecol. 2023;12(6):1844-8.
Jose A, Mahey R, Sharma JB, Bhatla N, Saxena R, Kalaivani M, Kriplani A. Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial. BMC Pregnancy Childbirth. 2019 Feb 4;19(1):54. doi: 10.1186/s12884-019-2200-3.
PubMed 30717690
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anemia in Pregnant Women
- ClinicalTrials.gov ID
- NCT06911034
- Acronym / sponsor ID
- U1111-1319-2291
- Conditions
- Iron Deficiency Anemia (IDA), Pregnancy
- Keywords
- Iron deficiency anemia, Pregnancy, Ferric carboxymaltose, Iron sucrose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CMH Multan Institute of Medical SciencesOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 4 Apr 2025 (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.
This clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women.
The main question it aimed to answer was:
Is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women.
Sixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments.
- Participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min.
- Participants in iron sucrose group were administered an infusion of 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.
Detailed description
The study was conducted after the ethics review committee approval. A total of 60 pregnant women presenting to the department of Obstetrics and Gynecology and fulfilling the eligibility criteria were enrolled in the study after informed consent. Patient's characteristics including age, parity, area of residence, educational status, socioeconomic status and baseline Hb were recorded. All women were administered anthelminthic therapy with tablet mebendazole 100 mg twice daily for three days and given 5 mg Folic acid once daily. Patients were be randomly assigned to group A \& B.
Patients in group A were treated with intravenous ferrous carboxymaltose and group B were given intravenous iron sucrose complex. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carboxymaltose | Experimental | Drug: Iron CarboxymaltoseIntravenous infusion |
| Sucrose | Active comparator | Drug: Iron Sucrose InjectionIntravenous infusion |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 28-34 weeks of gestation
- Iron deficiency anemia (IDA): IDA will be labelled if Hemoglobin is <10 gm% and serum Ferritin < 30 ng/ml.
Key exclusion criteria (3 listed)
- Hepatitis (serum transaminases more than 1.5 times the upper limit of normal) and HIV infection
- serum creatinine level of more than 2.0 mg/dL
- history of allergic reaction to intravenous iron infusion
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 |
|---|---|---|
| Iron CarboxymaltoseAlso: Ferrous CarboxymaltoseIn ferrous carboxymaltose treatment maximum dose per sitting was 1000 mg, diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again. | Drug | Carboxymaltose |
| Iron Sucrose InjectionAlso: sucroferric oxyhydroxide, Iron saccharateIron sucrose infusion was administered as 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again. | Drug | Sucrose |
Primary outcome
Change in hemoglobin
Time frame: After three weeks of completing parenteral iron therapy
Rise in hemoglobin (g/dl) will be calculated by subtracting post treatment hemoglobin from pre-treatment hemoglobin
1 secondary outcome
Ferritin levels
Time frame: Three weeks after completion of parenteral iron therapy
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 6 Apr 2025.
- BackgroundBharadwaj MK, Patrikar S, Singh Y. Comparative analysis of injection ferric carboxymaltose vs iron sucrose for treatment of iron-deficiency anemia in pregnancy: systematic review and meta-analysis. J South Asian Fed Obstet Gynaecol. 2023;15(5):629-36.
- BackgroundComparison of ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia in pregnancy at tertiary care centre, Western India. Int J Reprod Contracept Obstet Gynecol. 2023;12(6):1844-8.
- Background: PubMed 30717690Jose A, Mahey R, Sharma JB, Bhatla N, Saxena R, Kalaivani M, Kriplani A. Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial. BMC Pregnancy Childbirth. 2019 Feb 4;19(1):54. doi: 10.1186/s12884-019-2200-3.
- Individual participant dataSharing planned: No. Sharing IPD can compromise patient privacy, even if identifying details are removed. Sensitive medical information could potentially be re-identified, violating ethical guidelines.
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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.
Nidda Ya Consultant, FCPS study chair
CMH Multan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Carboxymaltose and Iron Sucrose Injection in people with Iron Deficiency Anemia (IDA) and Pregnancy, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
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 2 inclusion and 3 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 6 Apr 2025. 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 Pakistan. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in hemoglobin (time frame: After three weeks of completing parenteral iron therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06911034, which also lists 3 linked publications.
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 6 Apr 2025.