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.
Highlights
Iron deficiency during pregnancy is a preventable cause of several health problems in both the mother and infant, including an increased risk of anemia, premature birth, low birth-weight, developmental abnormalities, and postpartum depression [1,2]
Iron Absorption There were no significant differences in serum iron between the ferrous bisglycinate plus folinic acid group and the control group at baseline
We demonstrate that iron supplementation as ferrous bisglycinate with folinic acid and multivitamins improves hematological parameters, iron absorption, quality of life, and birthweight in iron-deficient pregnant women compared to ferrous fumarate
Summary
Iron deficiency during pregnancy is a preventable cause of several health problems in both the mother and infant, including an increased risk of anemia, premature birth, low birth-weight, developmental abnormalities, and postpartum depression [1,2]. Clinical and public health strategies for women and children have involved oral supplementation with mineral iron forms to counteract the depletion of iron stores during pregnancy and lactation. An alternative public health approach has been the fortification of food items with purified iron sources. Throughout these interventions, the most common challenges with oral supplementation have arisen from the significant variability in the bioavailability and oral tolerability of different iron forms, especially conventional mineral forms, such as ferrous sulfate [5]. Ferrous bisglycinate, has been demonstrated to have at least two-fold higher bioavailability and absorption compared to conventional iron salts, including ferrous sulfate and ferrous fumarate, while resulting in improved oral tolerability during pregnancy [6,7]. Utilization of iron sources with lower effective doses and improved compliance could alleviate the problems caused by inorganic iron and, most importantly, may prevent iron overload
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