Anemia, Iron DeficiencyPESONCT07163390
Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy
A study testing Sideral Folico in people with Anemia, Iron Deficiency and Pregnancy Anemia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Iron deficiency is the most frequent cause of anemia during pregnancy and of maternal blood transfusion during the post-partum period. Intravenous administration is the fastest route to correct iron deficiency, bypassing the filter of iron intestinal absorption, the only true mechanism of iron balance regulation in… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Anemia, Iron Deficiency, Pregnancy Anemia
- What is being tested?
- Sideral Folico
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women from 24 to 32 weeks of pregnancy
- Age ≥18 ys old
- Hemoglobin between 8.5 and 10.5 g/dl
- Ability to sign an informed written consent
Who cannot join
- Patients with preclampsia
- twin pregnancy
- chronic diseases
- drug exposure
- BMI<18 or >30
- malabsorption
Show all 11Show fewer
- fetal growth restriction
- age < 18 years
- haematologic diseases
- symptomatic anemia (dyspnea, tachycardia)
- inability to sign an informed written consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy: Evaluation of the Contribution of Sucrosomial Iron Supplementation (Sideral® Folico)
Iron deficiency is the most frequent cause of anemia during pregnancy and of maternal blood transfusion during the post-partum period. Intravenous administration is the fastest route to correct iron deficiency, bypassing the filter of iron intestinal absorption, the only true mechanism of iron balance regulation in the human body. Intravenous iron administration is suggested in patients who are refractory/intolerant to oral iron sulfate. This approach is expected to increase of at least 1 gr/dL the level of hemoglobin in 4 weeks. However, the intravenous route of iron administration has some drawbacks; first it is allowed only as in-hospital procedure and requires a resuscitation service, in accordance with the recommendations of the European Medicine Agency. Moreover, it is very expensive and negatively affects patient's perceived quality of life. A new oral iron formulation, Sucrosomial iron, bypassing the normal route of absorption, appears to be better tolerated and more cost-effective in correcting iron deficiency anemia at doses higher than those usually effective with other oral iron formulations. The hypothesis of the present study is that oral sucrosomial iron can correct iron deficiency anemia during pregnancy comparably to intravenous ferrous sulphate, with less side effects.
- Conditions
- Anemia, Iron Deficiency, Pregnancy Anemia
- Being tested
- Sideral Folico
- 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.
Sideral FolicoCombination product
Pregnant women will be enrolled from 24 to 32 weeks of gestation whether their hemoglobin levels are comprised between 8.5 and 10.5 g/dl. They start oral supplementation with Sucrosomial iron® 30 mg (Sideral® Folico), 2 sticks for twice a day for 15 days, followed by Sucrosomial iron ® 30 mg (Sideral® Folico), 1 stick for twice a day for the next 15 days
| Study group | Role | What they receive |
|---|---|---|
| iron deficiency anemia in pregnancy | Experimental | Women with ongoing pregnancy attending at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome will be prospectively enrolled from 24 to 32 weeks of pregnancy whether their hemoglobin levels are comprised between 8.5 and 10.5 g/dl. Patients will discontinue any other ongoing oral supplementation. Receives: Combination Product: Sideral Folico |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia correction
to evaluate the contribution of the product Sucrosomial iron® 30 mg (Sideral® Folico) to determine a rise of 1g/dl of haemoglobin in 30 days of supplementation. To this end the patients will undergo to the following exams:
- T0: evaluation of blood levels of Hb, Ferritin, sideremia, mean globular volume (MCV), transferrin saturation, Reactive C-Protein (PCR), according to routine clinical practice. Collection of medical and obstetric history and anthropometric parameters. Record of red meat consumption (more or less than twice a week).
These evaluations will be made after after 15 days from the beginning of the supplementation, according to routine clinical practice (T1) and after 30 days from the beginning of the supplementation (T2)
Measured: one month
Secondary outcomes (1)
Compliance of treatment
to evaluate the tolerability of the product Sucrosomial iron® 30 mg (Sideral® Folico) the Visual Analogue Scale (VAS) or the 0-10 numeric scale for gastrointestinal pain will be used. Other assessments include measuring the rate of nausea, constipation or diarrhea, and dark or black stools. All evaluations will be made at T0, T1 and T2.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giancarlo Paradisi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163390
- Sponsor's protocol ID
- 7816
- Acronym
- PESO
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy: Evaluation of the Contribution of Sucrosomial Iron Supplementation (Sideral® Folico)
- ClinicalTrials.gov ID
- NCT07163390
- Acronym / sponsor ID
- PESO / 7816
- Conditions
- Anemia, Iron Deficiency, Pregnancy Anemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 9 Sep 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.
Iron deficiency is the most frequent cause of anemia during pregnancy and of maternal blood transfusion during the post-partum period. Intravenous administration is the fastest route to correct iron deficiency, bypassing the filter of iron intestinal absorption, the only true mechanism of iron balance regulation in the human body. Intravenous iron administration is suggested in patients who are refractory/intolerant to oral iron sulfate. This approach is expected to increase of at least 1 gr/dL the level of hemoglobin in 4 weeks. However, the intravenous route of iron administration has some drawbacks; first it is allowed only as in-hospital procedure and requires a resuscitation service, in accordance with the recommendations of the European Medicine Agency. Moreover, it is very expensive and negatively affects patient's perceived quality of life. A new oral iron formulation, Sucrosomial iron, bypassing the normal route of absorption, appears to be better tolerated and more cost-effective in correcting iron deficiency anemia at doses higher than those usually effective with other oral iron formulations. The hypothesis of the present study is that oral sucrosomial iron can correct iron deficiency anemia during pregnancy comparably to intravenous ferrous sulphate, with less side effects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iron deficiency anemia in pregnancy | Experimental | Combination Product: Sideral FolicoWomen with ongoing pregnancy attending at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome will be prospectively enrolled from 24 to 32 weeks of pregnancy whether their hemoglobin levels are comprised between 8.5 and 10.5 g/dl. Patients will discontinue any other ongoing oral supplementation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women from 24 to 32 weeks of pregnancy
- Age ≥18 ys old
- Hemoglobin between 8.5 and 10.5 g/dl
- Ability to sign an informed written consent
Key exclusion criteria (11 listed)
- Patients with preclampsia
- twin pregnancy
- chronic diseases
- drug exposure
- BMI<18 or >30
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 |
|---|---|---|
| Sideral FolicoPregnant women will be enrolled from 24 to 32 weeks of gestation whether their hemoglobin levels are comprised between 8.5 and 10.5 g/dl. They start oral supplementation with Sucrosomial iron® 30 mg (Sideral® Folico), 2 sticks for twice a day for 15 days, followed by Sucrosomial iron ® 30 mg (Sideral® Folico), 1 stick for twice a day for the next 15 days | Combination product | iron deficiency anemia in pregnancy |
Primary outcome
Anemia correction
Time frame: one month
to evaluate the contribution of the product Sucrosomial iron® 30 mg (Sideral® Folico) to determine a rise of 1g/dl of haemoglobin in 30 days of supplementation. To this end the patients will undergo to the following exams: - T0: evaluation of blood levels of Hb, Ferritin, sideremia, mean globular volume (MCV), transferrin saturation, Reactive C-Protein (PCR), according to routine clinical practice. Collection of medical and obstetric history and anthropometric parameters. Record of red meat consumption (more or less than twice a week). These evaluations will be made after after 15 days from the beginning of the supplementation, according to routine clinical practice (T1) and after 30 days from the beginning of the supplementation (T2)
1 secondary outcome
Compliance of treatment
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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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.
Giancarlo Paradisi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
A study testing Sideral Folico in people with Anemia, Iron Deficiency and Pregnancy Anemia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giancarlo Paradisi (+39 0630155590, giancarlo.paradisi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia correction (time frame: one month). 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 9 Sep 2025.