Iron Deficiency Anaemia in ChildbirthPhase 1NCT07384663
EFFICACY OF IV VERSUS ORAL IRON IN THE TREATMENT OF IRON DEFICIENCY ANEMIA DURING PREGNANCY
A Phase 1 study testing Iron Carboxymaltose and Iron Polymaltose Complex in people with Iron Deficiency Anaemia in Childbirth, run by Dr Salaha Azam at 1 site in Pakistan.
Trial summary
This study was planned to compare outcomes of IV versus oral iron in the treatment of iron deficiency anemia during pregnancy. This study was used to investigate the efficacy of two new formulations of iron both in IV and oral form with fewer side effects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron Deficiency Anaemia in Childbirth
- What is being tested?
- Iron Carboxymaltose and Iron Polymaltose Complex
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 30 Nov 2025
- Phase
- Phase 1
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18 -45 years;
- Second trimester (gestational age 14-21 weeks);
- Females having hemoglobin level of < 11 g/dL
Who cannot join
- Multiple pregnancies,
- A history of multiple allergies, known hypersensitivity to any of the excipients in the investigational drugs,
- Active infections
- Recent red blood cell (RBC) transfusion
- Thalassemia minor
Trial locations and contacts
1 site in 1 country.
About this study
This study was planned to compare outcomes of IV versus oral iron in the treatment of iron deficiency anemia during pregnancy. This study was used to investigate the efficacy of two new formulations of iron both in IV and oral form with fewer side effects. We compared the efficacy of Intravenous Ferric Carboxymaltose with Oral polysaccharide iron complex. The better mode of treatment will be administered in future to treat this condition, that will surely improve the fetal and maternal outcome.
- Conditions
- Iron Deficiency Anaemia in Childbirth
- Being tested
- Iron Carboxymaltose, Iron Polymaltose Complex
- Keywords
- Anaemia, Iron Supplementation, Pregnancy
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron CarboxymaltoseDrug
Single dose of 500 mg Ferric carboxymaltose diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight is < 50 kg the dose was 10 mg/kg based on pre-pregnancy body weight). Infusions was administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion.
Iron Polymaltose ComplexDrug
Polysaccharide iron complex 150 mg capsule was administered daily till 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A participants who were administered Intravenous Iron supplementation (Ferric carboxymaltose ) | Active comparator | Treatment was initiated at the baseline visit. After baseline data was collected, women allocated to the IV iron group received a single dose of 500 mg Ferric carboxymaltose diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight is < 50 kg the dose was 10 mg/kg based on pre-pregnancy body weight). Infusions were administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma. Receives: Drug: Iron Carboxymaltose |
| Group B participants who were administered Oral Iron Supplementation (polysaccharide iron complex) | Active comparator | Women in the oral iron group received polysaccharide iron complex 150 mg capsule till 4 weeks. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma. Receives: Drug: Iron Polymaltose Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Haemoglobin Levels
Non Anaemic Levels are labelled as (Hb ≥ 11.0 g/dL) at 4th week
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Jun 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anaemia in ChildbirthStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Salaha Azam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Salaha Azam, Doctors Hospital and Medical Centre Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384663
- Sponsor's protocol ID
- 206
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF IV VERSUS ORAL IRON IN THE TREATMENT OF IRON DEFICIENCY ANEMIA DURING PREGNANCY
- ClinicalTrials.gov ID
- NCT07384663
- Acronym / sponsor ID
- 206
- Conditions
- Iron Deficiency Anaemia in Childbirth
- Keywords
- Anaemia, Iron Supplementation, Pregnancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Dr Salaha AzamUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 3 Feb 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.
This study was planned to compare outcomes of IV versus oral iron in the treatment of iron deficiency anemia during pregnancy. This study was used to investigate the efficacy of two new formulations of iron both in IV and oral form with fewer side effects. We compared the efficacy of Intravenous Ferric Carboxymaltose with Oral polysaccharide iron complex. The better mode of treatment will be administered in future to treat this condition, that will surely improve the fetal and maternal outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A participants who were administered Intravenous Iron supplementation (Ferric carboxymaltose ) | Active comparator | Drug: Iron CarboxymaltoseTreatment was initiated at the baseline visit. After baseline data was collected, women allocated to the IV iron group received a single dose of 500 mg Ferric carboxymaltose diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight is < 50 kg the dose was 10 mg/kg based on pre-pregnancy body weight). Infusions were administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma. |
| Group B participants who were administered Oral Iron Supplementation (polysaccharide iron complex) | Active comparator | Drug: Iron Polymaltose ComplexWomen in the oral iron group received polysaccharide iron complex 150 mg capsule till 4 weeks. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women aged 18 -45 years;
- Second trimester (gestational age 14-21 weeks);
- Females having hemoglobin level of < 11 g/dL
Key exclusion criteria (5 listed)
- Multiple pregnancies,
- A history of multiple allergies, known hypersensitivity to any of the excipients in the investigational drugs,
- Active infections
- Recent red blood cell (RBC) transfusion
- Thalassemia minor
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 CarboxymaltoseSingle dose of 500 mg Ferric carboxymaltose diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight is < 50 kg the dose was 10 mg/kg based on pre-pregnancy body weight). Infusions was administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion. | Drug | Group A participants who were administered Intravenous Iron supplementation (Ferric carboxymaltose ) |
| Iron Polymaltose ComplexPolysaccharide iron complex 150 mg capsule was administered daily till 4 weeks | Drug | Group B participants who were administered Oral Iron Supplementation (polysaccharide iron complex) |
Primary outcome
Blood Haemoglobin Levels
Time frame: 4 weeks
Non Anaemic Levels are labelled as (Hb ≥ 11.0 g/dL) at 4th week
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 3 Feb 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.
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 Phase 1 study testing Iron Carboxymaltose and Iron Polymaltose Complex in people with Iron Deficiency Anaemia in Childbirth, run by Dr Salaha Azam 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 3 inclusion and 5 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 3 Feb 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Blood Haemoglobin Levels (time frame: 4 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 3 Feb 2026.