Benefit of Iron Supplementation with Ferric Sodium EDTA (NaFe ³⁺-EDTA) in the Treatment of Anemia during Pregnancy in Democratic Republic of Congo (FERARI Study)

Background: Oral iron supplements, usually in the form of ferrous salts, are associated with gastric side effects, poor compliance and failure of anemia treatment. To make iron more bioavailable, reduce the gastric side effects and increase the patient compliance, newer iron form, Ferric Sodium EDTA, has become available on the market. Objective: To assess the change in hemoglobin level after iron supplementation with Ferric Sodium EDTA during pregnancy. Materials and Methods: This is a longitudinal study concerning 337 women attending antenatal care in maternity hospitals in the Democratic Republic of Congo from May to December 2020. The study included sociodemographic and anthropometric variables along with type of feed, hemoglobin level at recruitment and after three weeks of taking iron supplement with Ferric Sodium EDTA (Hemoforce Plus Zinc® syrup). For statistical analysis, we used t-test or ANOVA and chi-square test, the significance being stated at p < 0.05. Results: The frequency of pregnancy anemia was 51.4%. The mean hemoglobin value of the overall study group was 8.7 ± 0.5 g/dL. The mean maternal age and weight were 28.9 ± 6.2 years and 65.3 ± 11.7 kg, respectively. Most pregnant women (83.1%) had a diet consisting of food of plant and animal origin in equal proportions. Mean of Body Mass Index (BMI) was 24.6 ± 4.6 Kg/m2 and 44.3% were overweight and obese. The co-morbidities associated were malaria and intestinal parasitosis found in 45% and 5.9% of cases, respectively. After iron treatment with Ferric Sodium EDTA, the average hemoglobin level increased to 11.2 g/dL with mean gain of 2.5 g/dL (p < 0.001). Pregnant women with excess weight (≥90 kg) and malaria as a comorbidity achieved a significantly lower mean hemoglobin gain (p = 0.014 and p = 0.022, respectively). Majority of women (91.2%) had not experienced the metallic taste of the syrup. Conclusion: Ferric Sodium EDTA as a novel iron formulation (Hemoforce Plus Zinc®) has shown a rapid increase in hemoglobin levels in pregnant women suffering from anemia. The speedy rise in hemoglobin is related to the property of Ferric Sodium EDTA to enhance the iron absorption by inhibiting the dietary iron inhibitors. Thus, Ferric Sodium EDTA should be used as an effective and promising iron supplement in pregnant women with iron deficiency anemia.

食品强化剂EDTA铁钠制备新工艺研究

文章以氧化铁为原料,开发了一种EDTA铁钠生产新工艺,通过实验得的最佳工艺条件:反应助剂为铁粉和硫酸铁混合物,其加入量为氧化铁质量的5%,原料配比为n(EDTA)∶n(氧化铁)∶n(碳酸钠)为1∶1∶0.5,反应温度为90℃,反应时间为120min。制备的样品纯度高,其铁含量达到13.31%。母液循环利用,产品收率可达到90%。该工艺流程简单,产品铁含量高,制备成本低,产品收率高。

合成调渣剂中金属铝的分析研究

为了得到合成调渣剂中金属铝的准确含量，利用样品中三氧化二铝不溶解于三氯化铁而金属铝易溶解于三氯化铁的特性[1]，样品以三氯化铁浸取溶解，采用过滤消除三氧化二铝的干扰后，滤液用过量氢氧化钠强碱沉淀分离等操作，消除了铁、钙、镁及少量钛等干扰元素离子的影响，并根据合成调渣剂中金属铝的含量范围，拟定了用氟盐置换EDTA滴定法测定金属铝含量，测定结果令人满意，相对标准偏差小于1％。