ClinicalTrials.gg
Sign In
RecruitingNCT07884617Updated Oct 20, 2026

Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women

An interventional study of Iron plus folic acid and Folic acid in Iron Deficiency Anemia in Pregnancy and Iron Deficiency in Pregnancy, sponsored by IBSA Farmaceutici Italia Srl. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by IBSA Farmaceutici Italia Srl (part of IBSA Institut Biochimique SA) · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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).

02

Conditions studied

  • Iron Deficiency Anemia in Pregnancy
  • Iron Deficiency in Pregnancy

Keywords

  • iron supplementation
  • pregnancy
  • iron deficiency
  • iron deficiency anemia
  • iron homeostasis
03

In context

Iron Deficiencies

782 studies on the registry are indexed under Iron Deficiencies; 114 are open to participants now.

This study's planned enrollment of 162 is above the median of 100 across 600 interventional studies indexed under Iron Deficiencies.

Browse Iron Deficiencies studies →

Lead sponsor

IBSA Farmaceutici Italia Srl is the lead sponsor of 12 studies on the registry; 6 are open to participants now.

Browse IBSA Farmaceutici Italia Srl studies →All IBSA Institut Biochimique SA studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy Caucasian women aged 18-45 years.
  2. Single, viable pregnancy.
  3. Plasma ferritin levels in the first trimester ≤ 70 ng/mL.
  4. Hb levels in the first trimester ≥ 110 g/L.
  5. Understanding and signing of the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Anemia (Hb levels \< 110 g/L), adequate iron repletion (serum ferritin levels > 70 ng/mL).
  2. Multiple pregnancy (twins).
  3. Known comorbidities or chronic therapy administered to the pregnant.
  4. Maternal pathologies interfering with iron absorption (e.g. celiac disease, inflammatory bowel disease - IBD).
  5. Abnormal Hb electrophoresis result.
  6. Fetal anomalies detected during pregnancy.
  7. Specific diets (e.g. gluten-free, vegan, or vegetarian).
  8. 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.
  9. Obesity (pre-pregnancy Body Mass index, BMI ≥ 30kg/m2).
  10. Any clinical condition that is deemed not compatible with the study based on the Investigator's evaluation.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    Active

    Iron plus folic acid supplementation

    Dietary Supplement: Iron plus folic acid

  • Placebo comparator
    Placebo

    Folic acid supplementation

    Dietary Supplement: Folic acid

Interventions

  • Dietary supplementIron plus folic acid

    Drug pages: Iron · Folic Acid

    Ferro IBSA (ferric pyrophosphate 300mg + folic acid 400 mcg), one orodispensable film (ODF) once a day orally.

  • Dietary supplementFolic acid

    Folic acid 400 mcg, one orodispensable film (ODF) once a day orally.

06

What researchers measure

Primary outcomes

  1. Mean Hb levels

    Time frame: T2: 28th-30th week of pregnancy

Secondary outcomes

  1. Incidence of IDA in active and placebo groups

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  2. Change in total antioxidant capacity in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  3. Change in oxidative damage in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  4. Change in hepcidin concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  5. Change in Hb concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  6. Change in red blood cell count in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  7. Change in mean corpuscolar volume of red blood cells in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  8. Change in plasmatic ferritin concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  9. Change in plasmatic transferrin concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  10. Change in transferrin saturation levels in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  11. Change in C-reactive protein concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  12. Change in homocystein concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  13. Change in intra-erythrocic folate concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  14. Change in vitamine B12 concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  15. Differences in gestational age at delivery in active and placebo groups

    Time frame: T3: delivery time

  16. Differences in mode of delivery in active and placebo groups

    Time frame: T3: delivery time

  17. Differences in birth weight in active and placebo groups

    Time frame: T3: delivery time

  18. Differences in lenght at birth in active and placebo groups

    Time frame: T3: delivery time

  19. Differences in head circumference at birth in active and placebo groups

    Time frame: T3: delivery time

  20. Differences in placental weight in active and placebo groups

    Time frame: T3: delivery time

  21. Differences in fetal-placental weight ratio in active and placebo groups

    Time frame: T3: delivery time

  22. Differences in fetal oxygenation in active and placebo groups

    Time frame: T3: delivery time

  23. Differences in Apgar score at 1st an 5th minute in active and placebo groups

    Time frame: T3: delivery time

  24. Differences in blood loss in active and placebo groups

    Time frame: T3: delivery time

  25. Differences in obstetric complication rate, such as hypertensive disorders, in active and placebo groups

    Time frame: T3: delivery time

  26. Differences in FGR in active and placebo groups

    Time frame: T3: delivery time

  27. Differences in gestational diabetes mellitus (GDM) rate in active and placebo groups

    Time frame: T3: delivery time

  28. Differences in preterm birth number in active and placebo groups

    Time frame: T3: delivery time

  29. Differences in postpartum hemorrhage in active and placebo groups

    Time frame: T3: delivery time

  30. Gestational age at ultrasound in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  31. Biparietal diameter (BPD) mean in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  32. Head circumference mean in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  33. Abdominal circumference (AC) mean in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  34. Femur lenght (FL) mean in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  35. Estimated fetal weight (EFW) mean in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  36. Doppler velocimetry index of pulsatility in the uterine artery mean in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  37. Doppler velocimetry index of resistance in the uterine artery mean in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  38. Doppler velocimetry index of pulsatility in the umbilical artery mean in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  39. Doppler velocimetry index of resistance in the umbilical artery mean in active and placebo groups

    Ultrasound parameters from second- and third-trimester ultrasounds

    Time frame: T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy

  40. Nutritional lifestyle at baseline by questionnaire in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy

  41. Dietary iron intake at baseline by questionnaire in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy

  42. Product usability and acceptability by questionnaire

    Questionnaire based on a VAS scale (1-10, from very dissatisfied to very satisfied)

    Time frame: T2: 28th-30th week of pregnancy

Other outcomes

  1. Mean AST concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  2. Mean ALT concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  3. Mean gamma-GT concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  4. Mean creatinine concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  5. Mean ureal concentration in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  6. Number and type of adverse events (AE) in each subject in active and placebo groups

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

  7. Evaluation of gastro-intestinal symptoms by questionnaire in active and placebo groups

    Questionnaire to evaluate frequency and symptoms based on 6-point Likert scale (from 0=Never/Absent to 5=Every day/Severe)

    Time frame: T0: 11th+0-13th+6 week of pregnancy T1: 20th-22nd week of pregnancy T2: 28th-30th week of pregnancy T3: delivery time

07

Study locations

1 of 1 sites recruiting
  • SC Ostetricia - Clinica Mangiagalli, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    Milan, 20122, Italy
    • Principal Investigator · Contact · 02 5503.1
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07884617
Lead sponsor
IBSA Farmaceutici Italia Srl
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
May 18, 2026
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Iron · Folic Acid

Other studies in this condition

Iron Deficiencies →

Other studies from this sponsor

IBSA Farmaceutici Italia Srl →

Start the discussion