Iron Deficiency Anemia in PregnancyNCT07884617
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
A study testing Iron plus folic acid and Folic acid in people with Iron Deficiency Anemia in Pregnancy and Iron Deficiency in Pregnancy, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.
Trial summary
The clinical study aims to evaluate the effect of iron supplementation in preventing the onset of Iron Deficiency Anemia during pregnancy. The trial is designed as a double-arm, double-blind clinical study comparing iron supplementation versus placebo in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
- What is being tested?
- Iron plus folic acid and Folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteItaly
- Study dates
- 18 May 2026to Jun 2028
- Phase
- Interventional
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
- Healthy Caucasian women aged 18-45 years.
- Single, viable pregnancy.
- Plasma ferritin levels in the first trimester ≤ 70 ng/mL.
- Hb levels in the first trimester ≥ 110 g/L.
- Understanding and signing of the informed consent.
Who cannot join
- Anemia (Hb levels < 110 g/L), adequate iron repletion (serum ferritin levels > 70 ng/mL).
- Multiple pregnancy (twins).
- Known comorbidities or chronic therapy administered to the pregnant.
- Maternal pathologies interfering with iron absorption (e.g. celiac disease, inflammatory bowel disease - IBD).
- Abnormal Hb electrophoresis result.
- Fetal anomalies detected during pregnancy.
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- Specific diets (e.g. gluten-free, vegan, or vegetarian).
- Any nutritional supplement except for folic acid, vitamin D and/or isolated omega 3, and, in any case, based on the Investigator's case by-case evaluation.
- Obesity (pre-pregnancy Body Mass index, BMI ≥ 30kg/m2).
- Any clinical condition that is deemed not compatible with the study based on the Investigator's evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SC Ostetricia - Clinica Mangiagalli, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Principal Investigator, 02 5503.1
About this study
Official title: Randomized Double-blind Placebo-controlled Clinical Study to Evaluate the Effects and Safety of Iron Prophylaxis With Ferro IBSA on Iron Homeostasis in Healthy Pregnant Women.
The clinical study aims to evaluate the effect of iron supplementation in preventing the onset of Iron Deficiency Anemia during pregnancy. The trial is designed as a double-arm, double-blind clinical study comparing iron supplementation versus placebo in pregnant women. The primary objective is to assess the efficacy of iron supplementation in maintaining adequate levels of hemoglobin throughout gestation, while secondary outcomes include maternal hematological parameters and pregnancy outcomes.
Read the detailed description
During pregnancy, iron requirements progressively increase in order to meet the needs of the placenta and the growing fetus. Therefore, inadequate dietary iron intake may increase the risk of developing Iron Deficiency Anemia.
This clinical study proposes the use of an iron-based dietary supplement, in form of orodispersible film, to evaluate whether its intake during pregnancy may help to prevent the onset of iron deficiency anemia and its related consequences.
In this clinical study, participants will receive either iron plus folic acid (active) supplementation or folic acid alone (placebo), starting from the 11th-13th week of pregnancy and continuing until delivery. Treatment allocation will be randomized in a 2:1 ratio and double-blind. Approximately 162 women will be enrolled in the study. After the baseline visit (T0), two additional follow-up visits will take place at 20-22 weeks of gestation (T1) and 28-30 weeks of gestation (T2). The final visit will be conducted close to the time of delivery (T3).
- Being tested
- Iron plus folic acid, Folic acid
- Keywords
- iron supplementation, pregnancy, iron deficiency, iron deficiency anemia, iron homeostasis
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron plus folic acidDietary supplement
Ferro IBSA (ferric pyrophosphate 300mg + folic acid 400 mcg), one orodispensable film (ODF) once a day orally.
Folic acidDietary supplement
Folic acid 400 mcg, one orodispensable film (ODF) once a day orally.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Iron plus folic acid supplementation Receives: Dietary Supplement: Iron plus folic acid |
| Placebo | Placebo comparator | Folic acid supplementation Receives: Dietary Supplement: Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hb levels
Measured: T2: 28th-30th week of pregnancy
Secondary outcomes (42)
Incidence of IDA in active and placebo groups
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in total antioxidant capacity in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in oxidative damage in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in hepcidin concentration in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in Hb concentration in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in red blood cell count in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in mean corpuscolar volume of red blood cells in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in plasmatic ferritin concentration in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in plasmatic transferrin concentration in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in transferrin saturation levels in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in C-reactive protein concentration in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in homocystein concentration in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in intra-erythrocic folate concentration in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Change in vitamine B12 concentration in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time
Differences in gestational age at delivery in active and placebo groups
Measured: T3: delivery time
Differences in mode of delivery in active and placebo groups
Measured: T3: delivery time
Differences in birth weight in active and placebo groups
Measured: T3: delivery time
Differences in lenght at birth in active and placebo groups
Measured: T3: delivery time
Differences in head circumference at birth in active and placebo groups
Measured: T3: delivery time
Differences in placental weight in active and placebo groups
Measured: T3: delivery time
Differences in fetal-placental weight ratio in active and placebo groups
Measured: T3: delivery time
Differences in fetal oxygenation in active and placebo groups
Measured: T3: delivery time
Differences in Apgar score at 1st an 5th minute in active and placebo groups
Measured: T3: delivery time
Differences in blood loss in active and placebo groups
Measured: T3: delivery time
Differences in obstetric complication rate, such as hypertensive disorders, in active and placebo groups
Measured: T3: delivery time
Differences in FGR in active and placebo groups
Measured: T3: delivery time
Differences in gestational diabetes mellitus (GDM) rate in active and placebo groups
Measured: T3: delivery time
Differences in preterm birth number in active and placebo groups
Measured: T3: delivery time
Differences in postpartum hemorrhage in active and placebo groups
Measured: T3: delivery time
Gestational age at ultrasound in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Biparietal diameter (BPD) mean in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Head circumference mean in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Abdominal circumference (AC) mean in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Femur lenght (FL) mean in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Estimated fetal weight (EFW) mean in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Doppler velocimetry index of pulsatility in the uterine artery mean in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Doppler velocimetry index of resistance in the uterine artery mean in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Doppler velocimetry index of pulsatility in the umbilical artery mean in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Doppler velocimetry index of resistance in the umbilical artery mean in active and placebo groups
Ultrasound parameters from second- and third-trimester ultrasounds
Measured: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy
Nutritional lifestyle at baseline by questionnaire in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy
Dietary iron intake at baseline by questionnaire in active and placebo groups
Measured: T0: 11th+0-13th+6 week of pregnancy
Product usability and acceptability by questionnaire
Questionnaire based on a VAS scale (1-10, from very dissatisfied to very satisfied)
Measured: T2: 28th-30th week of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start18 May 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia in PregnancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IBSA Farmaceutici Italia Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884617
- Sponsor's protocol ID
- 25IT-Fe01
- Status last verified
- Oct 2026
- First submitted
- 14 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No