AnemiaNCT07115121
Comparison of the Mean Change in Hemoglobin With Ferric Carboxymaltose and IV Iron Sucrose in Anemic Antenatal Patients
A study testing Intravenous Ferric Carboxymaltose and Intravenous Iron Sucrose in people with Anemia, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Literature search has shows that both ferric carboxymaltose and iron sucrose complex are equally effective. Unfortunately, local data addressing this issue is scarce. To get further local data, the current study was planned with the objective to compare the mean change in hemoglobin with ferric carboxymaltose and IV… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anemia
- What is being tested?
- Intravenous Ferric Carboxymaltose and Intravenous Iron Sucrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Feb 2025to 31 Jul 2025
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women
- Aged 18 to 40 years
- Presented with anemia
- Any parity
- Gestational age < 12 weeks on LMP
Who cannot join
- Females with a history of hypertension
- Type II diabetes mellitus
- Gestational diabetes mellitus
- Ischemic heart disease
- Endocrine disorder
- Hematological disorders (hemophilia, leukemia, lymphoma, or myeloma)
- History of taking iron-lowering drugs
Trial locations and contacts
1 site in 1 country.
About this study
Literature search has shows that both ferric carboxymaltose and iron sucrose complex are equally effective. Unfortunately, local data addressing this issue is scarce. To get further local data, the current study was planned with the objective to compare the mean change in hemoglobin with ferric carboxymaltose and IV iron sources in anemic antenatal patients in our local population.
Read the detailed description
It was hypothesized that there was a difference in mean change in hemoglobin with ferric carboxymaltose as compared to IV iron sources in anemic antenatal patients. The findings of the study would be a valuable addition to the existing stats, and if the hypothesis stands correct, a large number of women of reproductive age would benefit from effective iron replacement therapy, with a comparatively low incidence of side effects.
- Conditions
- Anemia
- Being tested
- Intravenous Ferric Carboxymaltose, Intravenous Iron Sucrose
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Ferric CarboxymaltoseDrug
Patients were given ferric carboxymaltose as a maximum single dose of 1000 mg diluted in 250 mL of sterile 0.9% normal saline as a slow infusion over 45 minutes.
Intravenous Iron SucroseDrug
Patients received intravenous injections of iron sucrose complex, which contained 200 mg of elemental iron (equivalent to 2 ampoules of 5 ml), mixed in 100 ml of 0.9% normal saline and infused over a period of 30 minutes every other day for up to 5 doses.
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymaltose-Group | Experimental | Patients were given ferric carboxymaltose as a maximum single dose of 1000 mg diluted in 250 mL of sterile 0.9% normal saline as a slow infusion over 45 minutes. Receives: Drug: Intravenous Ferric Carboxymaltose |
| Iron Sucrose-Group | Experimental | Patients received intravenous injections of iron sucrose complex, which contained 200 mg of elemental iron (equivalent to 2 ampoules of 5 ml), mixed in 100 ml of 0.9% normal saline and infused over a period of 30 minutes every other day for up to 5 doses. Receives: Drug: Intravenous Iron Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in hemoglobin
Baseline hemoglobin was subtracted from post-treatment hemoglobin to assess increase in the hemoglobin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start2 Feb 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115121
- Sponsor's protocol ID
- Dr-Shamsa-BVH
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be share on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Mean Change in Hemoglobin With Ferric Carboxymaltose and IV Iron Sucrose in Anemic Antenatal Patients
- ClinicalTrials.gov ID
- NCT07115121
- Acronym / sponsor ID
- Dr-Shamsa-BVH
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 11 Aug 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.
Literature search has shows that both ferric carboxymaltose and iron sucrose complex are equally effective. Unfortunately, local data addressing this issue is scarce. To get further local data, the current study was planned with the objective to compare the mean change in hemoglobin with ferric carboxymaltose and IV iron sources in anemic antenatal patients in our local population.
Detailed description
It was hypothesized that there was a difference in mean change in hemoglobin with ferric carboxymaltose as compared to IV iron sources in anemic antenatal patients. The findings of the study would be a valuable addition to the existing stats, and if the hypothesis stands correct, a large number of women of reproductive age would benefit from effective iron replacement therapy, with a comparatively low incidence of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Carboxymaltose-Group | Experimental | Drug: Intravenous Ferric CarboxymaltosePatients were given ferric carboxymaltose as a maximum single dose of 1000 mg diluted in 250 mL of sterile 0.9% normal saline as a slow infusion over 45 minutes. |
| Iron Sucrose-Group | Experimental | Drug: Intravenous Iron SucrosePatients received intravenous injections of iron sucrose complex, which contained 200 mg of elemental iron (equivalent to 2 ampoules of 5 ml), mixed in 100 ml of 0.9% normal saline and infused over a period of 30 minutes every other day for up to 5 doses. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women
- Aged 18 to 40 years
- Presented with anemia
- Any parity
- Gestational age < 12 weeks on LMP
Key exclusion criteria (7 listed)
- Females with a history of hypertension
- Type II diabetes mellitus
- Gestational diabetes mellitus
- Ischemic heart disease
- Endocrine disorder
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 |
|---|---|---|
| Intravenous Ferric CarboxymaltosePatients were given ferric carboxymaltose as a maximum single dose of 1000 mg diluted in 250 mL of sterile 0.9% normal saline as a slow infusion over 45 minutes. | Drug | Ferric Carboxymaltose-Group |
| Intravenous Iron SucrosePatients received intravenous injections of iron sucrose complex, which contained 200 mg of elemental iron (equivalent to 2 ampoules of 5 ml), mixed in 100 ml of 0.9% normal saline and infused over a period of 30 minutes every other day for up to 5 doses. | Drug | Iron Sucrose-Group |
Primary outcome
Increase in hemoglobin
Time frame: 12 weeks
Baseline hemoglobin was subtracted from post-treatment hemoglobin to assess increase in the hemoglobin
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 5 Sep 2025.
- Individual participant dataSharing planned: No. Data can be share on a reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Ferric Carboxymaltose and Intravenous Iron Sucrose in people with Anemia, run by Muhammad Aamir Latif 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 5 inclusion and 7 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 5 Sep 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.
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?
Increase in hemoglobin (time frame: 12 weeks). 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 5 Sep 2025.