Oral Iron Salts Research Articles

Obesity and iron deficiency: what is the connection and how to treat?

The article presents a review of the literature and our own data on the etiology and pathogenesis of iron deficiency and iron deficiency anemia in patients with obesity. Obesity is considered as a subclinical systemic chronic inflammation, which is associated with an increase in the level of hepcidin, which is a key mediator of anemia during inflammation. Patients with obesity should undergo periodic screening of iron status and ferrokinetic parameters. Today, new oral iron preparations with increased tolerability and improved absorption are used in clinical practice. These include sucrosomial iron preparations. Sucrosomial iron (SI) is an innovative oral iron-containing carrier in which iron pyrophosphate is enclosed in a phospholipid matrix coated with sucrester, which protects sucrosomial iron from the effects of gastric juice, excluding contact with the mucous membrane of the gastrointestinal tract. Resistance to the action of gastric juice allows intact sucrosomes to reach the mucous membrane of the small intestine, where they are absorbed through special M cells, followed by the release of iron in liver cells. This allows prescribing SI to patients with iron deficiency and inflammatory bowel diseases, celiac disease, cancer and patients with obesity. Sucrosomial iron should be considered as an alternative treatment for iron deficiency in obese women. SI is innovative, allowing to bypass the “hepcidin barrier”, convenient for administration, effective for treatment, well tolerated than traditional oral iron salts.

Management of iron deficiency anemia in pregnancy in India: A review of current practices and challenges

Iron deficiency anaemia (IDA) is a major global health concern that can lead to difficulties for both the mother and the foetus, especially in pregnant women. The physiological demand of iron during pregnancy increases threefold to support fetoplacental development and maternal adaptation to pregnancy. This study aimed to identify gaps in current IDA management, limitations of conventional oral iron therapy, and the need for effective and well-tolerated treatments.The objective of this study was to understand the gap of current treatment options in IDA management, its limitations, and possible effective strategies for better management.A questionnaire-based opinion survey involving top gynecologists across India was conducted. The survey aimed to gather data on the challenges faced with conventional oral iron therapy, the desire for a change in oral iron salts, and the preference for novel oral iron prescriptions for their patients.Data obtained from the survey showed that 82% of gynecologists and obstetricians noticed challenges with conventional oral iron therapy. 86% wanted to change the oral iron salts, and 70% would like to prescribe novel oral iron for their patients. Ferric maltol, a novel form of chelated oral iron, was introduced as a potential solution for IDA management. It has been studied in various clinical indications, such as IDA associated with inflammatory bowel disease, chronic kidney disease, and pulmonary hypertension, showing significant improvements in hemoglobin and iron indices with good tolerability throughout treatment duration.The study results demonstrate that ferric maltol is a suitable and convenient treatment option for individuals seeking long-term, convenient, and well-tolerated management of IDA.

Comparative evaluation of different oral iron salts in the management of iron deficiency anemia.

Anemia affects one-fourth of the world's population and is caused mostly by iron deficiency. Iron supplementation is the most essential strategy for preventing iron deficiency anemia. Conventional oral iron salts have many drawbacks such as poor absorption & bioavailability, and poor tolerability resulting in poor clinical outcomes. To compare the effectiveness and safety of ferrous ascorbate, ferrous fumarate, ferrous bis-glycinate, and Sucrosomial iron in the management of iron deficiency anemia. The study is a retrospective observational clinical study comprising 260 subjects with hemoglobin between 7-10g/dl. The patients were divided into four groups I, II, III, and IV, and received ferrous fumarate, ferrous ascorbate, ferrous bis-glycinate, and Sucrosomial iron respectively. Hematological profile and iron store indices were measured at baseline and month 3. One-way ANOVA followed by Tukey multiple comparison test was used to assess statistical significance (P < 0.05) using GraphPad Prism V.9.3.1 software. The observational study showed that hemoglobin levels were significantly increased in the ferrous ascorbate group (11.86 ± 0.09; P < 0.0001), ferrous fumarate group (11.72 ± 0.08; P < 0.0001), ferrous bis-glycinate group (11.69 ± 0.11; P = 0.0003) and Sucrosomial iron group (12.20 ± 0.1; P < 0.0001) compared to the baseline. The Sucrosomial iron-supplemented group showed significantly higher improvement in hemoglobin levels and serum ferritin levels compared to conventional oral iron salts (P < 0.05) with a better safety profile. The Sucrosomial iron showed significantly higher improvement in hemoglobin levels and higher improvement in iron store indices parameters along with a good tolerability profile compared to other conventional oral iron salts.

Iron Uptake from Ferric Maltol in Patients with Iron Deficiency with or without Anemia: Post Hoc analysis of a Multicenter, Open-Label, Randomized, Phase 1 Clinical Study

Introduction: Iron deficiency is the most common nutritional disorder in humans, accounting for more than half of the estimated 1.76 billion cases of anemia worldwide (https://www.healthdata.org/). Anemia is a serious health problem, but, even without anemia, people with iron deficiency may experience fatigue, headaches, restless legs, and other physical and cognitive impairments, severely limiting their daily activities and quality of life. Patients may require long-term iron replacement therapy to replenish iron stores. Traditional oral iron salts are often associated with intolerable gastrointestinal toxicity and poor absorption. Ferric maltol is a European Medicines Agency- and U.S. Food and Drug Administration-approved oral iron formulation that was uniquely designed to improve gastrointestinal absorption, resulting in increased iron uptake while minimizing the risk of intestinal damage or dysbiosis. In a Phase 1 study in adults with inflammatory bowel disease and iron deficiency, ferric maltol increased iron uptake and storage over time at twice-daily doses of 30-90 mg (Bokemeyer B et al. Eur J Drug Metab Pharmacokinet 2017;42:229-238). We assessed iron measures following ferric maltol treatment in patients with iron deficiency with or without anemia. Methods: In post hoc analyses of data from 17 of the Phase 1 study participants (4 men, 13 women), who received twice-daily ferric maltol 30 or 60 mg, we compared total iron and transferrin saturation (TSAT) maximum concentration ( Cmax) and area under the curve up to 6 hours (AUC 6h) on Days 1 and 8 in subgroups with and without anemia. Data are reported as arithmetic means (standard deviation). Results: Four of the 17 patients (all female) had iron deficiency with anemia. Median (range) baseline hemoglobin levels were 107.5 (100-114) g/L in the subgroup with anemia and 135 (127-159) g/L in the subgroup without anemia. Total serum iron and TSAT values on Days 1 and 8 were similar between the subgroups with and without anemia (Table). Conclusions: These data demonstrate similar iron uptake from ferric maltol in patients with iron deficiency with or without anemia. Given the adverse impact of iron deficiency, even without anemia, iron-replacement therapy should be considered in anyone with an indication of low iron availability (e.g., ferritin &amp;lt;30 ng/mL with any TSAT value or ferritin &amp;lt;100 ng/mL with TSAT &amp;lt;20%), regardless of hemoglobin level. At the approved dose of 30 mg twice daily, ferric maltol is an effective, well tolerated, and convenient to take long-term iron-replacement therapy.

Sucrosomial® Iron: An Updated Review of Its Clinical Efficacy for the Treatment of Iron Deficiency.

Iron deficiency (ID) and iron deficiency anemia (IDA) are highly prevalent worldwide. Oral iron salts, especially ferrous sulfate, are commonly used for the treatment of iron deficiency (ID). However, its use is associated with gastrointestinal side effects, thus compromising treatment compliance. Intravenous iron administration is a more costly and logistically complex alternative and is not risk-free, as infusion and hypersensitivity reactions may occur. Sucrosomial® iron is an oral formulation consisting of ferric pyrophosphate conveyed by a phospholipid and sucrester matrix (sucrosome®). Intestinal Sucrosomial® iron absorption is mediated by enterocytes and M cells, through the paracellular and transcellular routes, and occurs mostly as intact particles. These pharmacokinetic properties of Sucrosomial® iron result in higher iron intestinal absorption and excellent gastrointestinal tolerance compared to oral iron salts. The evidence derived from clinical studies supports the use of Sucrosomial® iron as a valid first option for the treatment of ID and IDA, especially for subjects who are intolerant or refractory to conventional iron salts. Newer evidence also demonstrates the effectiveness of Sucrosomial® iron, with a lower cost and fewer side effects, in certain conditions usually treated with IV iron in current clinical practice.

Treatment protocol with alternative iron drugs in patients with an allergic reaction during iron replacement therapy

In our study, we aimed to show that alternative iron salts containing different additives are safe to use in patients who have type 1 hypersensitivity reactions to iron drugs and need iron replacement therapy. Materials and methods: Between January 2022 and June 2022, patients who had previously developed type 1 hypersensitivity reactions with iron preparations and needed iron replacement were included in the study. The study was designed retrospectively. Skin tests were first performed on patients to demonstrate a type 1 hypersensitivity reaction. If skin tests were negative and there was no history of life-threatening anaphylaxis, oral provocation tests were continued. If the absence of variability in symptoms and perimeter values, the drug allergy test was considered negative. Results: Twenty-two patients were included in the study. Twenty-one of the patients were female and one was male. Iron deficiency anemia was found in nine patients, and low iron stores in thirteen patients without anemia were found. Type 1 hypersensitivity reaction developed with Iron 3 Carboxymaltose in 7 patients, Iron 2 Sulfate in 5 patients, Iron 2 Glycine in 4 patients, Iron 3 Hydroxy Polymaltose in 4 patients, Iron 2 Fumarate in 1 patient and Iron 3 Hydroxide Sucrose in 1 patient. Allergy tests with all alternative iron drugs containing additional additives were negative. Conclusion: If patients with allergic reactions cannot be referred to allergy clinics, we think that oral iron salts with different additives can be used after the first dose is given in the hospital under general anaphylaxis precautions. We show that oral iron salts containing different additives can be safely used.

Iron Deficiency in Women's Health: New Insights into Diagnosis and Treatment.

Iron deficiency (ID), with or without anemia, is commonly found worldwide and affects the health and wellbeing of pregnant and nonpregnant women. Symptoms of ID- which include fatigue, pica (ice craving), restless legs syndrome, poor concentration and work function, increased susceptibility to infection, and cardiovascular stress- can cause significant morbidity and reduced quality of life. The etiologies of iron deficiency in women are usually specific to each community. In the developing world, iron deficiency is usually associated with poor iron intake and parasitic infections, whereas in higher income regions, iron deficiency is typically the result of heavy, abnormal uterine bleeding, and pregnancy. Iron-poor diets and poor iron absorption resulting from gut disorders can also play a role. Diagnosis of iron deficiency is usually straightforward and characterized by a low ferritin level; however, the diagnosis can be challenging in women with concomitant inflammatory disorders, in which case a low percent transferrin saturation, performed after an overnight fast, can inform on the need for iron. Therapy is frequently initiated with oral iron salts; however, use of these oral regimens is commonly associated with adverse events, mostly gastrointestinal in nature, that have been shown to adversely impact compliance, continuation, and the achievement of therapeutic goals. A further impediment to the effectiveness of oral iron is its poor absorption because of comorbidity (i.e., celiac disease, gastritis, etc.), surgery (bariatric), or physiologic inhibitory mechanisms. As such, intravenous (IV) iron regimens are increasingly being used to treat ID, as such regimens have been shown to avoid the gastrointestinal adverse events commonly associated with oral regimens. Indeed, IV iron has been shown to provide adequate iron replacement in women with functional iron deficiencies as well as those with ID resulting from inflammatory disorders- patients often resistant to oral iron therapy. More recent IV iron regimens have been shown to provide iron replacement in a safe and effective manner, being associated with more salutary adverse event profiles than earlier IV iron regimens. In fact, these iron regimens can provide a complete replacement dose in a single 15-60-min visit.

Anemia in children: a pediatrician’s view

Anemia is defined as a hemoglobin level that is two standard deviations below the mean for age. After children reach the age of 12, the hemoglobin norm can be further divided into gender-specific ranges. When a patient presents with anemia, it is important to establish whether the abnormality is isolated to a single cell line [red blood cells (RBC) only] or whether it is part of a multiple cell line abnormality. In children, anemia is usually caused by decreased RBC production or increased RBC turnover. Anemia is usually classified based on the size of RBC (microcytosis, normocytosis, or macrocytosis) as measured by the mean corpuscular volume. Although iron deficiency anemia is usually microcytic, some patients may have normocytic blood cells. From a practical point of view, it is better to use in children the etiologic classification of anemia which includes impaired red cell formation, blood loss and hemolytic anemia. Most children with anemia are asymptomatic, and the condition is detected on screening laboratory evaluation. Iron deficiency can be treated with oral iron, intravenous iron, and/or blood transfusion, depending on the patient`s hemoglobin levels, tolerance and co-morbidity. Oral iron salts are usually the first line of treatment for uncomplicated iron deficiency, but are poorly absorbed and lead to gastrointestinal side effects. In some cases, iron refractory iron deficiency anemia (IRIDA), a hereditary recessive anemia refractory to oral iron, occurs. IRIDA shows a slow response to intravenous iron and partial correction of anemia.

Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study

Background: Low preoperative haemoglobin is frequently observed in heart surgery patients and is associated with a significant decrease in haemoglobin between post-operative days 2 and 3, known as haemoglobin drift. Overall, these patients tend to receive many RBC transfusions. Since iron homeostasis is often impaired in these patients, restoration of iron availability might override iron-restricted erythropoiesis. However, reduced tolerance to oral iron salts has limited this strategy to intravenous iron administration. Study Design and Methods: The purpose of this study was to assess whether preoperative supplementation with oral sucrosomial iron, a new iron-delivery technology with improved tolerance and bioavailability, might be an effective strategy for this patient population. One thousand consecutive patients were randomized and received either a one-month course of sucrosomial iron (60 mg/day) or no treatment prior to elective heart surgery at a single high-volume centre (ClinicalTrials.gov NCT03560687). Primary end-points were haemoglobin concentration on the day of hospital admittance and number of blood transfusions. Secondary end-points were haemoglobin drift, tolerance of treatment and cost-effectiveness of sucrosomial iron administration. Results: Baseline haemoglobin in the treatment group was higher (by 0.67 g/dL; p&lt;0.001) than that in the control group. The percentage of patients in the treatment group who required transfusion (35.4%) was half that in the control group (64.6%). The average number of transfused units per operation was 0.95 vs. 2.03 in the treatment and control groups, respectively. Haemoglobin drift was substantially similar in the two groups, and the tolerability of treatment was excellent (98%). The overall cost of treatment was 156 Euros less in the treatment group, expressed as a raw cost of transfusion. Conclusion: In elective heart surgery, routine preoperative sucrosomial iron administration seems to be a safe, well-tolerated and cost-effective strategy to increase preoperative haemoglobin and reduce the need for allogeneic blood transfusions.

Sucrosomial Iron Supplementation for the Treatment of Iron Deficiency Anemia in Inflammatory Bowel Disease Patients Refractory to Oral Iron Treatment.

Iron deficiency anemia (IDA) is a common manifestation of Inflammatory Bowel Disease (IBD). Oral iron supplements are the treatment of choice, but are not always well tolerated. Sucrosomial® iron (SI) may represent an alternative. This prospective study assessed the tolerability and effectiveness of SI, and quality of life (QoL) of IDA-IBD patients who were intolerant to oral iron salts. The study included 52 individuals treated with 1 capsule/day for 12 weeks. Tolerability was assessed through a gastrointestinal symptom severity questionnaire. Hemoglobin (Hb) levels and clinical symptoms of IDA were analyzed. QoL was assessed using IBDQ-9 and EuroQoL questionnaires. The percentage of patients with excellent/good health increased from 42.9% to 94.3%. Mean Hb concentration significantly increased at all follow-up visits (p < 0.05). Almost all participants (96.9%) were adherent to the study medication. Patients’ QoL improved (IBDQ-9: from 60.9 to 65.5). Patients also improved in mobility (71.8% to 78.1%), usual activities (51.3% to 68.7%), pain/discomfort (41.0% to 53.1%), and extreme depression/anxiety problems (7.7% to 3.2%); they worsened in self-care (100% to 90.6%), but perceived an enhancement in their global health [EQ-VAS score: 61.9 (±26.1) to 66.9 (±20.3)]. SI was well tolerated and improved IDA symptoms, IBD activity, and patients’ QoL. In conclusion, SI should be considered in IDA–IBD patients.

Ferric Maltol: A New Oral Iron Formulation for the Treatment of Iron Deficiency in Adults.

To review the pharmacology, efficacy, and safety of ferric maltol (FM), an oral iron formulation, for iron deficiency anemia (IDA). A MEDLINE/PubMed and EMBASE (January 1, 1985, to June 19, 2020) literature search was performed using the terms ferric maltol, accrufer, feraccru, iron maltol, ferric trimaltol, iron deficiency, iron deficiency anemia, inflammatory bowel disease, and chronic kidney disease. Additional data sources included prescribing information, abstracts, and the National Institutes of Health Clinical Trials Registry. English language literature evaluating FM pharmacology, pharmacokinetics, efficacy, or safety in the treatment of IDA were reviewed. FM is a ferric, non-salt-based oral iron formulation demonstrating improved tolerance in patients with previous intolerance to other iron formulations. Phase 3 trials demonstrated significant improvements in anemia and serum iron parameters in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Common adverse effects were gastrointestinal intolerance. FM is an effective and well-tolerated alternative to oral iron salts for patients with IBD or CKD and IDA. Emerging data suggest that FM is noninferior to intravenous (IV) ferric carboxymaltose in patients with IBD and IDA. Prior to selecting FM over IV iron products, consideration should be given to time to normalization of Hb, ease of administration, cost, and tolerability. FM is a relatively safe, effective oral iron therapy that may be better tolerated than other oral iron formulations. FM may be an effective alternative to IV iron in patients with IBD.

Efficacy of a Novel Food Supplement (Ferfer®) Containing Microencapsulated Iron in Liposomal Form in Female Iron Deficiency Anemia.

IntroductionIron deficiency anemia (IDA) is a highly afflicting condition which affects young children of growing age and reproductive age women in countries of lower economies. Conventional oral iron salts have poor absorption and gastrointestinal side effects. Microencapsulated liposomal iron pyrophosphate is a novel compound with enhanced palatability, higher bioavailability, and consequently increased adherence among people with IDA. This study aims to assess the efficacy of microencapsulated iron pyrophosphate sachets in non-pregnant women with IDA.MethodsIt was a 12-week long, open label clinical trial conducted with 558 IDA women. Participants were advised one sachet of microencapsulated liposomal iron pyrophosphate (Ferfer®) twice daily. At baseline, and every four-week interval, serum hemoglobin levels and taste tolerability were assessed. Data was entered and analyzed using SPSS v. 24 (IBM Corp, Armonk, NY, USA).ResultsFour hundred and thirty-seven women completed the trial. The mean serum Hb level at baseline was 8.71 ± 2.24 which increased to 10.47 ± 1.69 by the end of 12 weeks (p < 0.001).ConclusionTreatment of IDA with microencapsulated liposomal iron pyrophosphate sachets significantly increases serum hemoglobin levels in non-pregnant women of reproductive age.

Sucrosomial® Iron: A New Generation Iron for Improving Oral Supplementation.

Iron deficiency (ID) is usually treated with oral iron salts, but up to 50% of patients complain of gastrointestinal side effects, leading to reduced compliance with treatment. Intravenous (IV) iron formulations are increasingly safe, but there is still a risk of infusion, hypersensitivity reactions and the need for venous access and infusion monitoring. Sucrosomial® Iron (SI) is an innovative oral iron formulation in which ferric pyrophosphate is protected by a phospholipid bilayer plus a sucrester matrix (sucrosome), which is absorbed through para-cellular and trans-cellular routes (M cells). This confers SI’s unique structural, physicochemical and pharmacokinetic characteristics, together with its high iron bioavailability and excellent gastrointestinal tolerance. The analysis of the available evidence supports oral SI iron as a valid option for ID treatment, which is more efficacious and tolerable than oral iron salts. SI has also demonstrated a similar effectiveness, with lower risks, in patients usually receiving IV iron (e.g., chronic kidney disease, cancer, bariatric surgery). Thus, oral SI emerges as a valuable first option for treating ID, especially for subjects with intolerance to iron salts or those for whom iron salts are inefficacious. Moreover, SI should also be considered as an alternative to IV iron for initial and/or maintenance treatment in different patient populations.

Heme iron polypeptide in treatment of anemia inpregnancy

Introduction: Treatment of iron deficiency anemia with non-heme iron salts still remains a challenge. The negative influence of various dietary elements and medications slows the absorption of iron from iron salts which makes it less bio-available, the side effects associated with iron salts, results in poor compliance. But Heme Iron Polypeptide claims to overcome the short comings of the non – heme oral iron. Materials and Methods: This prospective clinical study was done on patients of SSG Hospital, Baroda; 100 mild to moderate anemia pregnant patients between 16 to 28 weeks were included. The primary outcome of interest was mean maternal hemoglobin and serum ferritin levels at the end of treatment. Secondary outcomes were treatment related side effects and compliance. Results: There was significant rise in hemoglobin [mean difference (MD), 1.05841; p< 0.001] and serum ferritin [mean difference (MD) 7.3715, p, 0.001]. No side effects and good compliance with Heme Iron Polypeptide. Conclusion: Heme Iron Polypeptide is promising supplementary treatment for iron deficiency anemia in pregnancy as there was significant rise in hemoglobin and other iron indices which are comparable to oral iron salts. Heme Iron Polypeptide is a better source of iron for iron deficiency anemia in pregnancy, as it has less side effects especially gastrointestinal side effects, because of which it has better compliance.

Effects of Sucrosomial® iron in Pre-Clinical and Clinical Conditions of Inflammation

Introduction: Proteins such as Ferritin (Ft), Hemoglobin (Hb) and Transferrin Receptor (TfR1) are involved in tissue iron distribution while systemiciron metabolism is regulated by Hepcidin. Interleukin-6 (IL-6) release is induced in response to an inflammatory status and enhances Hepcidin expression, as consequence, dietary iron absorption and macrophage iron recycling are inhibited. Anemia of Chronic Disease (ACD) is a form of anemia associated with many different chronic disorders. It is characterized by high hepcidin and CRP or IL-6 expression and low serum iron transferrin concentration while ferritin can be normal or elevated. Oral iron delivery is especially attractive thanks to the ease of administration, but commonly used iron salts are poorly absorbed and ineffective to increase Hb concentration in particular in patients with ACD. We have developed an oral Iron formulation named Sucrosomial® Iron, preparation of ferric pyrophosphate, covered by a phospholipids plus sucrester matrix, with high bioavailability and tolerability, which promotes ferric iron absorption thanks to gastro-resistant and matrix composition properties and showed Hb concentration improvement not inferior to intravenous iron.Objective: to showpre-clinical and clinical evidences of absorption, effectiveness and tolerability of Sucrosomial Iron using in vivo and in vitro models and in patients with ACD too.Methods: To study the effects of oral supplementation on Iron metabolism and inflammatory status, Hb, Ft, TfR1, Socs3 and Hepcidin expression were analyzed. We have supplemented wild-type (wt) and iron deficient (ID) mice, maintained in iron-free diet for 8 weeks, with 1mg/kg/die of Sucrosomial® Iron or Iron Sulfate or Placebo by oral gavage, for 2 weeks. The role of Sucrosomial® Iron on the inflammatory response, was studied in LPS induced HepG2 hepatoma cells. Cells were treated with Sucrosomial® Iron and the levels of hepcidin were assessed 6, 18 and 24 hours after treatment. To show the efficacy and compliance of Sucrosomial® Iron a multi-centric randomized study on 300 patients with ACD were performed. Patients were supplemented with iron sulfate (65 mg o.i.d.), microencapsulated iron, micronized iron, Sucrosomial® Iron, heminic-chelated bisglycinated and iron chelated bisglycinated iron (30 mg t.i.d.). Median Hb value at the beginning was 8.2 g/dl. In group of patients with high CRP value median Hb value was 7.8 g/dl.Results: In mice treated with Sucrosomial® Iron, Hb level mean increase was 4,9 g/dl while TSAT value is not significantly higher than animals treated with Sulfate Iron. Furthermore mice treated with Sucrosomial® Iron showed a preferential accumulation of iron in spleen. Hepcidin and Socs3 mRNA expression was not induced during Sucrosomial® Iron treatment while was up-regulated in mice treated with Iron Sulfate (Figure 1). In vitro experiments on HepG2 LPS-induced cells displayed that treatment with Sucrosomial Iron® is able to reduce hepcidin concentration at different time points (Figure 2).Data from the clinical study showed that Sucrosomial® Iron is well tolerate and effective ACD patients. Only patients treated with Sucrosomial® Iron showed constant increase in Hb concentration over time. In all groups Hb level achieves a plateau phase after three months and ferritin level starts to increase. At three months higher levels of Hb are present in Sucrosomial® Iron (13.2 g/dl), heminic chelated bisglycinated iron (11.7 g/dl), chelated bisglycinated iron (11.3 g/dl) treated patients. In patients with high CRP level (>30 ng/ml) only those receiving Sucrosomial® Iron showed Hb increase from the tenth week and this continue up to the sixth month (Hb 12.5 g/dl) and seems to be correlated to a significantly decrease of CRP (5 mg/L) (Figure 3). Side effects are higher in ferrous sulfate (15/50) and sunactive treated groups (6/60).Conclusions: In summary, results showed that Sucrosomial® Iron treatment could regulate iron homeostasis through an increase in Hb concentration and better tolerability during inflammatory status. These evidences may suggest that this new oral iron formulation behaves differently than other oral iron salts, perhaps due to different absorption pathways. Besides we have observed a decrease in CRP and Hepcidin concentration, these results should be further investigate. [Display omitted] DisclosuresBrilli:Pharmanutra S.p.A.: Consultancy. Pera:Pharmanutra S.p.A.: Employment. Tarantino:Pharmanutra S.p.A.: Employment.

Iron deficiency: new insights into diagnosis and treatment.

Iron deficiency and iron deficiency anemia are common conditions worldwide affecting especially children and young women. In developing countries, iron deficiency is caused by poor iron intake and/or parasitic infection, whereas vegetarian dietary choices, poor iron absorption, and chronic blood loss are common causes in high-income countries. Erythropoiesis stimulating agents can result in functional iron deficiency for erythropoiesis even when stores are iron-replete. Diagnosis of iron deficiency is straightforward, except when it occurs in the context of inflammatory disorders. Oral iron salts correct absolute iron deficiency in most patients, because low hepcidin levels facilitate iron absorption. Unfortunately frequent side effects limit oral iron efficacy. Intravenous iron is increasingly utilized, because currently available preparations allow rapid normalization of total body iron even with a single infusion and are effective also in functional iron deficiency and in iron deficiency associated with inflammatory disorders. The evidence is accumulating that these preparations are safe and effective. However, long-term safety issues of high doses of iron need to be further explored.

Comparison of Various Oral Iron Salts in the Treatment of Iron Deficiency Anemia in Pregnancy

Background: To compare the efficacy and side effects of ferrous sulphate, fumarate, ascorbate, sodium feredetate and ferrous bisglycinate in the treatment of iron deficiency anemia in pregnancy. Material and methods: The study is a prospective, randomized, comparative clinical study comprising of 250 antenatal women with hemoglobin between 7-10 gm %. The patients divided into five groups I, II,III,IV and IV of fifty each, by systematic randomization and were treated with ferrous sulphate (100mg), ferrous fumarate (100mg), ferrous ascorbate (100mg), ferrous bisglycinate (30 mg), sodium feredetate (33 mg) respectively. Hemoglobin estimation was done at day 0, 30 and 60 and serum ferritin levels were done on day 0 and 60. Results: There was significant and comparable rise in hemoglobin on day 30 and day 60 in all the five groups (p

Treatment of mild non-chemotherapy-induced iron deficiency anemia in cancer patients: Comparison between oral ferrous bisglycinate chelate and ferrous sulfate

In cancer patients mild-moderate non-chemotherapy-induced iron deficiency anemia (IDA) is usually treated with oral iron salts, mostly ferrous sulfate. In this study, we compare efficacy and toxicity of oral ferrous bisglycinate chelate and ferrous sulfate in cancer patients with mild IDA. Twenty-four patients operated on for solid tumors (10 breast, 12 colorectal, 2 gastric), aged 61±10years (range 45–75), with non-chemotherapy-induced hemoglobin (Hb) values between 10 and 12g/dL and ferritin lower than 30ng/mL were randomized to receive oral ferrous bisglycinate chelate, 28mg per day for 20days, and then 14mg per day for 40days (12 patients) (A group) or oral ferrous sulphate, 105mg per day for 60days (12 patients) (B group). Values of hemoglobin and ferritin obtained at diagnosis, 1 and 2months from the beginning of treatment were compared. Adverse events (AEs) related to the two treatments were recorded. In the 12 patients treated with ferrous bisglycinate chelate, basal hemoglobin and ferritin values (mean±SD) were 11.6±0.8g/dL and 16.1±8.0ng/mL. After 2months of treatment, they were 13.0±1.4g/dL and 33.8±22.0ng/mL, respectively (P=0.0003 and P=0.020). In the group treated with ferrous sulphate, hemoglobin and ferritin mean values were 11.3±0.6g/dL and 19.0±6.4ng/mL basally, and 12.7±0.70g/dL and 40.8±28.1ng/mL (P<0.0001 and P=0.017) after 2months of treatment. AEs occurred in six cases. In all these six cases, two (17%) treated with ferrous bisglycinate chelate and four (33%) with ferrous sulphate, toxicity was grade 1. In conclusion, these data suggest that ferrous bisglycinate chelate has similar efficacy and likely lower GI toxicity than ferrous sulphate given at the conventional dose of 105mg per day for the same time.

Policy statement on iron deficiency in pre‐school‐aged children

We aimed to develop policy in relation to three areas: (i) the diagnosis of iron deficiency; (ii) maternal-infant issues and the prevention of iron deficiency; and (iii) the treatment of iron deficiency. Within each of these topic areas we completed a literature review and developed recommendations to help direct activities of the Royal Australasian College of Physicians, update paediatricians and guide clinical practice. Iron deficiency can be defined using cut-off values for laboratory measures of iron status or, if an intercurrent infection is not present, by demonstrating a response to a therapeutic trial of iron. The appropriate measures of iron status vary depending upon the presence of intercurrent infection. Full-term babies are born with iron stores sufficient to meet their needs to age 4-6 months but premature infants are not. After age 6 months infants are dependent upon dietary iron from complementary foods even with continued breastfeeding. Infants <33 weeks gestation or <1800 g birthweight should receive iron from 4 weeks of age. In most settings recommended treatment of iron deficiency is with oral ferrous sulphate as a single or twice daily dose of between 3 and 6 mg/kg/day. Iron deficiency is prevalent and an important determinant of child health. Precise and accurate diagnosis remains challenging. Iron supplementation is required for premature and low-birthweight infants. Oral iron salts remain the recommended treatment of choice in most instances.

Screening for iron deficiency.

1. Ann Chen Wu, MD* 2. Leann Lesperance, MD, PhD* 3. Henry Bernstein, DO*† 1. *Pediatric Health Associates, Hunnewell Ground Children’s Hospital 2. †Associate Professor of Pediatrics, Harvard Medical School, Boston, MA After completing this article, readers should be able to: 1. Determine the most common cause of iron deficiency in the United States. 2. Describe the pathogenesis of iron deficiency. 3. List populations at high risk for iron deficiency. 4. Outline the common signs and symptoms of iron deficiency. 5. Specify the American Academy of Pediatrics recommendations for screening for iron deficiency. In the March and April issues of Pediatrics in Review, we published a two-part article on managing anemia in a pediatric office practice. This article expands on the various tests for iron deficiency, including some relatively new ones. These articles should be read as complementary.—RJH Iron deficiency is the most common nutritional deficiency in the world, responsible for a staggering amount of ill health, lost productivity, and premature death. Although its prevalence in the United States has declined since the late 1960s, iron deficiency with or without anemia still is seen frequently in infants, toddlers, adolescent females, and women of childbearing age. In fact, iron deficiency anemia remains the most common hematologic disease of infants and children. Anemia is defined as a low hemoglobin (Hgb) concentration or red blood cell (RBC) mass compared with age-specific norms. Anemia may be caused by decreased RBC production, increased RBC destruction, or blood loss. Based on the size of the RBC, hematologists categorize anemia as macrocytic, normocytic, or microcytic. Iron is found in different compartments within the body. Total body iron (measured by ferritin), transport iron (measured by transferrin saturation), serum iron, and other hematologic and biochemical markers are used to describe the degrees of iron deficiency. Iron depletion refers to the earliest stage of diminishing iron stores in the setting of insufficient iron supply. Iron deficiency (without anemia) develops as these iron stores are depleted further and begin to impair Hgb synthesis. Finally, iron deficiency anemia results …