NCT07163390

Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy

Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy: Evaluation of the Contribution of Sucrosomial Iron Supplementation (Sideral® Folico)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Sideral Folico	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

Timeline

• Start date: 2025-09-15
• Primary completion: 2027-07-15
• Completion: 2027-09-15
• First posted: 2025-09-09
• Last updated: 2025-09-09