Efficacy and Safety of Ferrous Bisglycinate and Folinic Acid in the Control of Iron Deficiency in Pregnant Women: A Randomized, Controlled Trial

Abstract

Iron deficiency in pregnancy is a major public health problem that causes maternal complications. The objective of this randomized, controlled trial was to examine the bioavailability, efficacy, and safety of oral ferrous bisglycinate plus folinic acid supplementation in pregnant women with iron deficiency. Subjects (12–16 weeks of gestation, n = 120) were randomly allocated to receive oral iron as ferrous bisglycinate (equiv. iron 24 mg) in supplement form with folinic acid and multivitamins (test group, n = 60) or as ferrous fumarate (equiv. iron 66 mg iron, control group, n = 60) after breakfast daily. Iron absorption was assessed by measuring fasted serum iron levels at 1 and 2 h immediately after supplementation. Hematological biomarkers and iron status were assessed before intervention, and at 3 and 6 months. Side effects were monitored throughout the intervention. A significant increase in serum iron was seen in both groups (p < 0.001) during the bioavailability assessment; however, the test group increases were comparatively higher than the control values at each timepoint (p < 0.001). Similarly, both test and control groups demonstrated a statistically significant increases in hemoglobin (Hb) (p < 0.001), erythrocytes (p < 0.001), reticulocytes (p < 0.001), mean corpuscular volume (MCV) (p < 0.001), mean corpuscular hemoglobin (MCH) (p < 0.001), mean corpuscular hemoglobin concentration (MCHC) (p < 0.001), % transferrin saturation (p < 0.001), and ferritin (p < 0.001) at 3 and 6 months after supplementation. However, in all cases, the test group increases were numerically larger than the control group increases at each timepoint. The test intervention was also associated with significantly fewer reports of nausea, abdominal pain, bloating, constipation, or metallic taste (p < 0.001). In conclusion, ferrous bisglycinate with folinic acid as a multivitamin nutraceutical format is comparable to standard ferrous fumarate for the clinical management of iron deficiency during pregnancy, with comparatively better absorption, tolerability, and efficacy and with a lower elemental iron dosage.

Real-world evaluation of safety and effectiveness of ferrous bis-glycinate and its combination in pregnant women with iron deficiency anemia

“…Furthermore, Bumrungpert et al showed that ferrous bisglycinate 30 mg was as effective as 120 mg of ferrous sulfate in preventing IDA and with more persistent correction of ferritin levels after a six-month follow-up. 9 The chelated iron preparation improved hematological parameters, iron absorption, quality of life, and birthweight in iron-deficient pregnant women compared to ferrous fumarate. 9 A comparison of a few previously done studies with ferrous bis-glycinate and the present one is depicted in (Table 1).…”

“…9 The chelated iron preparation improved hematological parameters, iron absorption, quality of life, and birthweight in iron-deficient pregnant women compared to ferrous fumarate. 9 A comparison of a few previously done studies with ferrous bis-glycinate and the present one is depicted in (Table 1).…”

“…8 Common challenge with conventional oral supplementation is significant variability in the bioavailability and tolerability of different iron forms. 9 The major disadvantage of traditional ferrous salts is the frequent gastrointestinal (GI) side effects such as nausea, vomiting, abdominal colic, and constipation which affects the patients' adherence to treatment and the efficacy of iron preparation. 9 Due to the GI side effects associated with conventional iron forms, alternatives have included iron chelates.…”

“…9 The major disadvantage of traditional ferrous salts is the frequent gastrointestinal (GI) side effects such as nausea, vomiting, abdominal colic, and constipation which affects the patients' adherence to treatment and the efficacy of iron preparation. 9 Due to the GI side effects associated with conventional iron forms, alternatives have included iron chelates. 9 In light of this evidence, a retrospective study was designed to evaluate the safety, effectiveness, tolerability, and compliance of ferrous bis-glycinate and it's combination as iron supplementation for the treatment of iron deficiency anemia (IDA) during pregnancy.…”

“…9 Due to the GI side effects associated with conventional iron forms, alternatives have included iron chelates. 9 In light of this evidence, a retrospective study was designed to evaluate the safety, effectiveness, tolerability, and compliance of ferrous bis-glycinate and it's combination as iron supplementation for the treatment of iron deficiency anemia (IDA) during pregnancy.…”