levoleucovorin and Anemia--Iron-Deficiency

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.

Topics: Anemia, Iron-Deficiency; Biomarkers; Female; Ferrous Compounds; Glycine; Humans; Iron Deficiencies; Leucovorin; Pregnancy; Pregnancy Complications

To evaluate whether folate supplementation to iron is able to accelerate solving of iron deficiency anaemia in pregnancy.. Multicentre, double blind, randomised clinical trial.. Nine hospital gynaecologic units located in Mexico.. Three hundred seventy-one women with iron deficiency anaemia between 14 and 27 weeks of pregnancy.. Random allocation of the study population to receive 80 mg iron proteinsuccinylate, with or without 0.370 mg folinic acid daily for 60 days.. Haemoglobin concentration increase.. Combined iron and folate therapy showed a better therapeutic response: the increase in haemoglobin levels from baseline was 1.42 (0.14) g/dL for women treated with both compounds vs 0.80 (0.125) g/dL for those given iron only (P < 0.001). A multivariable regression analysis showed that this effect was independent of basal levels of blood iron, ferritine and serum folate and was more evident in women with more severe anaemia. In the 64 women belonging to the subgroup defined by the per-protocol (PP) population and the lowest quartile of baseline haemoglobin values (mean 8.96, range 5.9-9.8 g/dL), the increase at day 60 was estimated 2.3 (0.53) g/dL for the combined therapy vs 0.5 (0.5) g/dL for iron only (P = 0.07). No significant differences in tolerability were observed between the two groups.. Folate supplementation is recommendedin pregnant women with iron deficiency anaemia irrespective of the serum levels of folate.

Topics: Adult; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferritins; Hemoglobins; Humans; Iron; Leucovorin; Metalloproteins; Multivariate Analysis; Pregnancy; Pregnancy Complications, Hematologic; Regression Analysis; Succinates