Effectiveness of a new oral iron co-processed compound (FERALGINE™) in pregnant women affected by iron deficiency anemia: A prospective clinical trial

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Marco Bertini, F Minelli, P Re, P Petruzzelli and G Menato

Laboratori Baldacci SpA, Italy
Sant ’ Anna Hospital, Italy

: Androl Gynecol: Curr Res

Abstract

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Statement of the Problem: Iron requirements drastically increase during pregnancy to accommodate an expanding red cell volume, growing fetus and placenta. Anemia in pregnancy has an estismated global prevalence of 38%. Oral iron treatment is still considered a frontline therapy for Iron Deficiency Anemia (IDA) in pregnancy but gastrointestinal side effects are common leading to a high ratio of non-adherence to treatment. FERALGINE™ (a new co-processed compound between Sodium Alginate and Ferrous Bisglycinate Chelate) is a new oral iron repletion treatment that has recently demonstrated to be safe and effective in clinical practice.

Aim: The purpose of this study was to describe the experience of supplementation with only 30 mg of elemental iron/ daily belonging to FERALGINE™ in 21 pregnant women affected by moderate IDA (Hb<11 g/dl and Ferritin<25 ng/ ml).

Methodology & Theoretical Orientation: During the period between November 2017 and February 2018 we have consecutively enrolled in this prospective clinical trial 21 pregnant women in every gestational age affected by moderate IDA (T0 values=Hb<11.0 g/dl and Ferritin<25 ng/ml). The women were treated with 1 cps daily of TECNOFER™ PLUS (FERALGINE™) 30 mg of elemental iron for 30 days and Hb and Ferritin have been evaluated after 15 days (T1) and after 30 days (T2) of treatment.

Findings: All the enrolled women increased, in a statistically significant manner, their Hb and Ferritin levels after 15 days (T1) and 30 days (T2) of treatment (Hb T1 vs. T0 p<0.004; T2 vs. T0 p<0.00001 and T2 vs. T1 p<0.003) (Ferritin T1 vs. T0 p<0.0001; T2 vs. T0 p<0.00001; T2 vs. T1 p<0.05).

Conclusion & Significance: Thanks to its pharmacodynamic profile a little quantity of elemental iron (30 mg) belonging to FERALGINE™ administered by oral route has demonstrated to be effective also after a very short time (15 days) to restore Hb and Ferritin in pregnant women affected by moderate IDA without gastrointestinal adverse effects.

Recent Publications:

1. S E Juul, R J Derman and M Auerbach (2019) Perinatal iron deficiency: Implications for mothers and infants. Neonatology 115(3):269-274.

2. A M Abbas, A S Abdelbadee and A Alanwar (2018) Efficacy of ferrous bis-glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia with pregnancy: A randomized double-blind clinical trial. J Maternal-Fetal & Neonaatal Med. 1-7.

3. G B Gervasi, M Baldacci and M Bertini (2016) Feralgine® a new co-processed substance to improve oral iron bioavailability, taste and tolerability in iron deficiency patients. Arch Med, 8(4):13.

4. C A Ame (2016) FERALGINE® a new oral iron therapy for iron deficiency anemia: Preliminary clinical results on a case series of 12 anemic patients. Research & Reviews: Pharmacy & Pharmaceutical Sciences, 5(4):29-35.

5. M B Rondinelli, A Di Bartolomei, A De Rosa and L Pierelli (2017) Oral iron absorption test (OIAT): A forgotten screening test for iron absorption from the gastrointestinal tract. A case series of 14 iron deficiency anemia (IDA) patients treated with FERALGINE®. J Blood Dis Med, 2:1.

Biography

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Marco Bertini has his expertise in Clinical Pharmacology. He is a Medical Doctor with a PhD in Clinical Pharmacology and Pediatrics. He was teaching Clinical Pharmacology at Pisa University, Italy and is actually involved in R&D in a Pharmaceutical Company (Laboratori baldacci SpA). He has published more than 100 articles on different medical topics and was invited as “Speaker” in different international congresses. He is an Editorial Board Member of different international journals and is actively involved in Translational Medicine.