Ferrous Sulfate Group Research Articles

Oral Lactoferrin versus Ferrous Sulfate for the Treatment of Iron Deficiency Anemia during Second Trimester among Egyptian ladies

Abstract Background Iron deficiency anemia (IDA) is a major public health problem in Egypt, especially among pregnant women. The most commonly used treatment is oral administration of iron as ferrous sulfate which often fails to exert significant effects with many adverse effects. Lactoferrin is a glycoprotein which belongs to proteins capable of binding and transferring iron. This study was done to evaluate the effectiveness, safety and acceptability of lactoferrin in comparison to ferrous sulfate. Methods This randomized clinical trial was conducted in outpatient clinic under supervision of department of Obstetrics and Gynecology, Faculty of medicine, Ain Shams University, Cairo, Egypt from August 2019 to February 2020. 140 women with iron deficiency anemia in second trimester were recruited and randomly assigned to either group. First group received lactoferrin 200 mg sachets once daily and second group received 100 mg of dried ferrous sulfate capsules twice daily for 4 consecutive weeks. Hemoglobin, hematocrit levels, mean corpuscular volume, and serum ferritin were assessed before and after therapy. Results The increase in haemoglobin was significantly higher in lactoferrin group. Number of cases achieved Hb level ≥10.5 was significantly more frequent in lactoferrin group. Compliance was significantly more frequent in lactoferrin group than in ferrous sulfate group. Maternal side effects were significantly less frequent in lactoferrin group than in ferrous sulfate group. Conclusion Oral lactoferrin is well tolerated and effective as compared to traditional treatment by ferrous sulfate.

Ferrous Sulphate Alone Versus Combination of Ferrous Sulphate and Lactoferrin for The Treatment of Iron Deficiency Anemia during Pregnancy and Their Effect on Neonatal Iron Store: A Randomized Clinical Trial

Iron deficiency anemia (IDA) is a frequent medical condition that causes disturbing pregnancies, especially in low-resource nations, and it contributes considerably to morbidity and mortality. As a result, early detection and treatment of IDA are strongly advised. Objective: This study was conducted to evaluate the effectiveness, safety and acceptability of ferrous sulphate alone in comparison to combination of ferrous sulphate and lactoferrin for the treatment of iron deficiency anemia during pregnancy and their effect on neonatal iron store. Patients and methods: This randomized prospective cohort study was conducted on 300 pregnant women from the second trimester with IDA who were enrolled and randomly separated on 2 groups; ferrous sulphate group: 150 pregnant women received 150 mg of dried ferrous sulphate capsules. Combined ferrous sulphate and lactoferrin group: 150 pregnant women received combined 200 mg lactoferrin and 30 mg iron once daily for eight consecutive weeks. Results: Total increase in CBC with combined ferrous sulphate and lactoferrin was higher compared to ferrous sulfate alone (p value < 0.05). Gastrointestinal adverse effects occurred more frequently with ferrous sulphate than the combined ferrous sulphate and lactoferrin (p < 0.05). Neonatal iron store significantly increased in combined ferrous sulphate and lactoferrin than in ferrous sulphate alone (p value < 0.001). Conclusion: Combined ferrous sulphate and lactoferrin was more effective than ferrous sulfate in pregnant women with IDA, with fewer gastrointestinal adverse effects and better effect on neonatal iron store.

The Comparison of Iron Deficiency Anemia Rat Treated with Hydroxypropyl Chitosan Ferrous Ion Complex and Ferrous Sulfate

To observe and compare the therapeutic effects of hydroxypropyl chitosan ferrous ion complex solution and ferrous sulfate solution in iron deficiency anemia rats and their effects on gastric mucosa. Seven rats were randomly selected from thirty five SPF grade SD rats as control group, and were fed with normal diet, distilled water (E). The rest of SD rats were fed with low iron feed and distilled water plus continuous tail vein bloodletting to establish the iron deficiency anemia model. After the model was established successfully, the rats were randomly divided into four groups: blank control group (A), iron deficiency anemia control group (B), ferrous sulfate group (C), hydroxypropyl chitosan ferrous ion complex (HPCTS-Fe2+) group (D). Group A was killed and the gastric tissue was taken to make the pathological section. Group E was fed with normal feed and distilled water continually. Group B, C and D were fed with low iron feed and distilled water. Moreover, Group C and group D were treated with ferrous sulfate solution and HPCTS-Fe2+ solution respectively to made the blood recover treatment (4 mg / kg of iron each time, twice a day). During the treatment period, Ret%, SF and blood routine were checked regularly. After 6 weeks of treatment, the rats were killed, and the gastric tissue was taken to make the pathological section, and the condition of gastric mucosa was observed by the light microscope. After modeling, except the normal control group, the hair color of the rats in the four groups showed dark yellow and the belly of the toes became white gradually. HGB, HCT, Ret%, MCV, MCH, MCHC and SF decreased significantly (P < 0.05). After treatment, the rats with dark yellow hair in group C and D were improved, and the toe abdomen turned pink gradually. RBC, HGB, HCT, Ret%, MCV, MCH, MCHC and SF in rats in group C and D increased, which were higher than those in group B (P < 0.05). The HGB of the rats in group D was higher than that of group C in day 28th during treatment and the Ret% was higher than that in group C at day 10th (P<0.05).After treatment, the liver and spleen of the rats in group C and D were lighter than those in group B (P<0.05).The gastric mucosa in group A, B, D and E was not damaged obviously, while it was slightly irritated and damaged in group C. Hydroxypropyl chitosan ferrous complex solution can improve the hemoglobin level of SD rats with iron deficiency anemia, which is stronger than ferrous sulfate solution and shows no damage to gastric mucosa.

Ferric carboxymaltose vs. ferrous sulfate for the treatment of anemia in advanced chronic kidney disease: an observational retrospective study and cost analysis

In non-dialysis-dependent chronic kidney disease (NDD-CKD), erythropoiesis-stimulating agents (ESAs) and iron supplementation are essential for anemia management. Ferric carboxymaltose (FCM) is a relatively novel intravenous iron formulation used in different clinical settings, although scarce data exist in NDD-CKD patients. Primary objective of this study was to retrospectively evaluate the efficacy of FCM compared with oral ferrous sulfate for the treatment of iron-deficiency anemia in a cohort of NDD-CKD patients, considering also the treatment costs. This was a monocentric, retrospective observational study reviewing 349 NDD-CKD patients attending an outpatient clinic between June 2013 and December 2016. Patients were treated by either FCM intravenous infusion or oral ferrous sulfate. We collected serum values of hemoglobin, ferritin and transferrin saturation (TSAT) and ESAs doses at 12 and 18 months. The costs related to both treatments were also analysed. 239 patients were treated with FCM intravenous infusion and 110 patients with oral ferrous sulfate. The two groups were not statistically different for age, BMI and eGFR values. At 18 months, hemoglobin, serum ferritin and TSAT values increased significantly from baseline in the FCM group, compared with the ferrous sulfate group. ESAs dose and rate of infusion decreased only in the FCM group. At 18 months, the treatment costs, analysed per week, was higher in the ferrous sulfate group, compared with the FCM group, and this was mostly due to a reduction in ESAs prescription in the FCM group. Routine intravenous FCM treatment in an outpatient clinic of NDD-CKD patients results in better correction of iron-deficiency anemia when compared to ferrous sulfate. In addition to this, treating NDD-CKD patients with FCM leads to a significant reduction of the treatment costs by reducing ESAs use.

Compliance and Efficacy of Oral Lactoferrin versus Ferrous Sulfate in Treatment of Nutritional Iron Deficiency Anemia during Second Trimester among Egyptian Ladies

Background: Nutritional iron deficiency anemia is of a major concern in Egypt, especially during pregnancy. The most commonly used treatment is oral iron mainly as ferrous sulfate. Unfortunately, ferrous sulfate has low efficacy with many adverse effects. Lactoferrin is a glycoprotein which belongs to proteins which have the ability to bind and transfer iron. This study was done to assess the compliance, efficacy and safety of lactoferrin in comparison to ferrous sulfate. Methods: This randomized clinical trial was conducted in outpatient clinic under supervision of Department of Obstetrics and Gynecology, Faculty of medicine, Ain Shams University, Cairo, Egypt from August 2019 to February 2020. 140 women with iron deficiency anemia in second trimester were recruited and randomly assigned to either group. First group received lactoferrin 200 mg sachets once daily and second group received 100 mg of dried ferrous sulfate capsules twice daily for 4 consecutive weeks. Compliance to treatment, efficacy and side effects were recorded. Results: Compliance is better in lactoferrin group in comparison to ferrous sulfate group. Maternal side effects were significantly less common in lactoferrin group than in ferrous sulfate group. The increase in hemoglobin was significantly higher in lactoferrin group. Number of cases achieved Hb level ≥10.5 was more frequent in lactoferrin group. Conclusion: Oral lactoferrin is more tolerated and effective as compared to traditional treatment by ferrous sulfate.

A comparative study between the dispersible Ferric pyrophosphate particles and Ferrous sulfate in treatment of pediatric patients with iron deficiency anemia

Background: Iron deficiency anemia (IDA) is the most common type of anemia related to malnutrition worldwide. It represents a major problem in developing countries, especially in Egypt. Ferric pyrophosphate (FPP) is a water-insoluble iron compound often used to fortify infant cereals and chocolate drink powders. It causes no adverse color and flavor changes to food vehicles. This study was done to compare the efficacy of FPP (micro dispersed iron) and ferrous sulfate (FS) in treating childhood IDA. Materials and Methods: This prospective cohort study was conducted on 58 anemic children visiting the outpatient clinic, pediatric department of Menoufia University hospitals from March 2017 to June 2019. The inclusion criteria of the involved children were age 2 - 12 years and the diagnosis of IDA. Patients with other types of anemia were excluded from the study. Verbal permission was obtained from the parents of the children according to the ethical committee of Menoufia University. Patients were randomly divided into 2 groups. Group1 included 29 children who were treated with FPP and group2 included 29 children who were treated with oral traditional iron in the form of FS. Complete blood count and iron profile were recorded before and after 8 weeks of treatment. Results: The results showed no statistically significant difference between the FPP group and the FS group regarding clinical examinations (P-value &gt; 0.05). There was no significant difference regarding hemoglobin, serum iron, and serum ferritin between the FPP and the FS groups after treatment (P-value&gt; 0.05). However, side effects were significantly higher in the FS group (P-value &gt; 0.001). Conclusion: Micro dispersed iron could be used as an alternative therapy for children with IDA who refuse oral iron therapy in a liquid form with more tolerability and fewer side effects.

Comparison of efficacy & safety of iron polymaltose complex & ferrous ascorbate with ferrous sulphate in pregnant women with iron-deficiency anaemia.

Background & objectives:Iron-deficiency anaemia (IDA) is a common nutritional deficiency among pregnant women in India. It has a significant impact on the health of the mother as well as that of the foetus. IDA generally responds well to treatment with oral iron supplementation. However, oral iron supplements are toxic to the gastrointestinal mucosa and intolerance is common, resulting in poor compliance and failure of treatment. The iron salts such as iron hydroxide polymaltose complex (IPC) and ferrous ascorbate (FeA) are claimed to have low gastrointestinal intolerance, therefore better patient compliance than the conventionally used ferrous sulphate (FS). These preparations also claim to increase haemoglobin level faster as well as improve the iron storage better than FS. This study was done to compare the efficacy and safety of FS with IPC and FeA.Methods:It was a randomized, parallel, open label, study among pregnant women of gestational age between 12 to 26 wk with moderate anaemia. Patients were randomly allocated to receive either FS, IPC or FeA. They were then followed up for 90 days to observe for improvement in the haemoglobin levels and other haematological parameters or any adverse drug reaction.Results:The haemoglobin levels were comparable in the three groups except at day 90 when FeA group had significantly higher haemoglobin level as compared to FS group (P<0.05). The overall adverse effect profiles were also comparable among the study groups except epigastric pain which was more commonly reported in the FS group.Interpretation & conclusions:The results of the study showed that FS, IPC and FeA have comparable efficacy and safety profile in the treatment of IDA of pregnancy.

Effect Camel’s milk in male albino mice exposed to ferrous sulfate toxic

This study was aimed to search the effect of Camel milk on males albino mice exposed to ferrous sulfate toxic 30 mg / kg body weight for period 30 days. The animals were randomly divided into 3 groups, each group comprising 5 animals that weigh 26-27 gm. The results of oral dose were shown with ferrous sulfate a significant decrease in (P <0.05) in body weight, MON, GRAN, HCB, HCT. And significant increase (P<0.05) in kidney, spleen, LYM, MCHC, AST, ALT, Urea. And no significant difference in the heart, liver, WBC, RBCs, MCV, MCH, Protein and Albumin compared with the control group. As for the results of oral dosage of Camel’s milk + ferrous sulfate appeared a beneficial effect of these values compared to the group given ferrous sulfate. The oral dose of ferrous sulfate causes pathological histopathological changes in the kidneys and liver of male mice. The tissue is Separation of central venous wall from Hepatocyte and the Existence of congestion in the liver and Clear hemorrhage within the kidney tissue with a clear contraction of renal glomerulosclerosis in the kidneys. The treatment with Camel’s milk + ferrous sulfate showed the return of central vein and hepatocytes to a semi-natural condition with congestion remaining within the central vein in the liver and showing Glomerulus and urinary tubules are almost normal in the kidneys. Showed an effect to reduce damage or damage completely in certain areas of the tissue compared to ferrous sulfate group.

Efficacy of a High-Iron Dietary Intervention in Women with Celiac Disease and Iron Deficiency without Anemia: A Clinical Trial.

Background and Aim. Iron deficiency without anemia (IDWA) is a common finding in celiac disease (CD) and can also persist in case of good compliance and clinical response to a strict gluten-free diet (GFD). This scenario usually presents in CD women of child-bearing age in whom the imbalance between menstrual iron loss and inadequate iron intake from their diet plays the major role. A recommended approach to this condition is yet to be established. This study aimed to compare, in this subset of patients, the efficacy of a dietary approach consisting of an iron-rich diet against the traditional pharmacological oral-replacement therapy. Material and Methods. Between February and December 2016, consecutive CD female patients of child-bearing age as referred to our outpatient center with evidence of IDWA (ferritin <15 ng/mL or 15–20 ng/L with transferrin saturation <15%) were enrolled. After the completion of a 7-day weighed food intake recording to assess the usual iron dietary intake, the patients were randomized in two arms to receive a 12-week iron-rich diet (iron intake >20 mg/die) versus oral iron supplementation with ferrous sulfate (FS) (105 mg/day). Blood tests and dietary assessments were repeated at the end of treatment. The degree of compliance and tolerability to the treatments were assessed every month by means of specific questionnaires and symptoms evaluation. Results. A total of 22 women were enrolled and divided in the diet group (n = 10, age 37 ± 8 years) and in the FS group (n = 12, age 38 ± 10 years). The food intake records demonstrated an inadequate daily intake of iron in all the enrolled subjects. At the end of the treatments, ferritin levels were higher in the FS group (8.5 (5) versus 34 (30.8), p = 0.002). Compliance and tolerability were similar in both treatment groups (89% versus 87%, p = ns). Conclusions. These findings did not support any equivalent efficacy of an iron-rich diet compared to a FS supplementation in non-anemic iron-deficient women affected by CD. However, the diet appeared a well-tolerated approach, and adequate dietary instructions could effectively increase the daily iron consumption, suggesting a role in the long-term management of IDWA, especially in patients who do not tolerate pharmacological supplementation.

Comparison of Conventional and Newer Iron Preparations for the Treatment of Iron Deficiency Anaemia in Children

Introduction: Commonly used iron salt, ferrous sulphate for the treatment of iron deficiency anemia, has several gastrointestinal side effects. Nowadays new iron salts such as ferrous bisglycinate are marketed with claims of raising hemoglobin faster with fewer gastrointestinal side effects.&#x0D; Objective: To compare the efficacy of ferrous sulphate with ferrous bisglycinate for the treatment of iron deficiency anemia in children.&#x0D; Methods: This randomized controlled trial was carried out at Children Hospital, PIMS, Islamabad from July 2015 to June 2016. A total of 136 children were selected through systematic sampling and randomized into 2 groups using a computer-generated table of random numbers; ferrous sulphate as group 1 and ferrous bisglycinate as group 2. Clinical outcome was assessed on the basis of a mean increase in hemoglobin after 12 weeks of therapy in both groups. The data was entered and analyzed using SPSS version 20. &#x0D; Results: The baseline characteristics i.e. mean age, mean hemoglobin levels were similar in both study groups. After 12 weeks of treatment, the mean increase in hemoglobin was 1.8 ±1.59 g/dl in ferrous sulphate group as compare to 2.5 ±1.31g/dl in ferrous bisglycinate group showing the higher level of rising with ferrous bisglycinate than ferrous sulphate, P =0.0033.&#x0D; Conclusion: Newer iron preparation, ferrous bisglycinate is a better treatment option than conventional preparation of ferrous sulphate for increasing hemoglobin in iron deficiency anemia in children.

A Comparative Study between Lactoferrin versus ferrous sulfate in iron-deficiency during pregnancy

Abstract Background Iron deficiency anemia (IDA) is the condition in which there is decrease in the number of red blood cells or the amount of hemoglobin in the blood. It is caused by insufficient dietary intake and absorption of iron, or iron loss from bleeding. Bleeding can be from a range of sources such as the intestinal, uterine or urinary tract. Aim of the Work to compare the efficacy and the safety of lactoferrin versus ferrous sulphate for the treatment of iron deficiency pregnant women. Patients and Methods This randomized clinical trial was conducted on 98 women selected from pregnant women attending the antenatal outpatient clinic of Ain Shams University Maternity hospital. All patients were divided into two groups; the first group included 49 pregnant women who received lactoferrin (Pravotin100 mg sachets, Hygint pharmaceuticals, Egypt) twice daily orally for 30 days which was dissolved in 1/4 glass of water before meals by 15 minutes. The second group included 49 pregnant women who received 520 mg of dried ferrous sulphate tablets (Feosol tablets, Meda pharmaceuticals, Egypt) once daily orally for 30 days on empty stomach but may be taken with meals to avoid stomach upset. Results Total increase in HB after 1month with lactoferrin was higher compared to ferrous sulfate (-13.572 gdl)(p &amp;lt; 0.001). Gastroinestinal adverse events occurred more frequently with ferrous sulfate than the lactoferrin group (p &amp;lt; 0.001).The number of women requesting change the drug was higher in the ferrous sulfate group(p &amp;lt; 0.001). Conclusion Oral lactoferrin was better tolerated and more acceptable with higher increase in mean hemoglobin when compared to oral iron therapy over one month treatment. Oral lactoferrin can be used as a good substitute to oral iron therapy in iron deficiency during pregnancy.

Influences of different Fe sources on Fe bioavailability and homeostasis in SD rats.

The purpose of this study was to determine whether the enteric coating process affects growth performance, Fe bioavailability, and gene expression levels that maintain iron balance in the body. The test was divided into the control group, ferrous sulfate group, ferrous fumarate group, ferrous glycinechelate(1:1) (Fe-Gly(1:1)) group, ferrous glycinechelate(2:1) (Fe-Gly(2:1)) group, enteric-coated Fe-Gly(1:1) group, and enteric-coated Fe-Gly(2:1) group. The results showed that the growth performance of the rats in each iron supplement group was no significant difference among them. The results of serum biochemical indicators showed that the antioxidant capacity of the rats in the iron supplement group after enteric coating increased. The iron supplementation effect of Fe-Gly(1:1) and Fe-Gly(2:1) was better than that of ferrous sulfate, and the effect of Fe-Gly(1:1) after enteric coating was enhanced. The expression levels of IRP1 and IRP2 in the genes of enteric-coated Fe-Gly(1:1) and enteric-coated Fe-Gly(2:1) were significantly higher than those of ferrous sulfate. The expression levels of IRP1 and IRP2 in the protein of enteric-coated Fe-Gly(1:1) group were significantly higher than those in the Fe-Gly(1:1) group. The above results show that Fe-Gly can improve the bioavailability and antioxidant capacity of iron and reduce the iron output of feces after enteric coating.

Assessing the Efficacy of Bovine Lactoferrin to Correct Iron Deficiency Anemia in Non-pregnant Non-lactating Women: A Randomized Controlled Trial (FS08-02-19)

Objectives1. To determine if bovine lactoferrin (bLf) is at least as effective as oral ferrous sulfate in iron deficiency anemia in non-pregnant women of reproductive age (WRA)2. To determine the optimal dose of oral bLf3. To compare the side-effects of the treatments MethodsDesign: Non-inferiority, double-blind, individually RCT in non-pregnant WRA with iron deficiency anemia (Hb <12 g/dl & serum ferritin <30 μg/L) SettingMirpur, Dhaka, Bangladesh Participants555 non-pregnant, non-lactating women of 15–49 years. InterventionsWomen were allocated individually (1:1:1) in three arms. Arm A, B and C received daily oral 200 mg bLf, 400 mg bLf and 60 mg ferrous sulfate. All received 400 μg of folic acid daily. Treatment was for 12 weeks. OutcomesSerum Hb and serum ferritin at baseline and every 30 days for 3 months. Inflammatory markers: C-reactive protein (CRP); alpha(1)-Acid glycoprotein (AGP); hepcidin, at baseline and end line. Possible adverse effects were assessed. ResultsWomen on 200 mg bLf had a decrease in Hb of 0.3 g/dl (95% CI, −0.60 to 0.00 g/dl, P = 0.05), women on 400 mg bLf arm had no change in Hb: 0.0 g/dl (95% CI, −0.32 to 0.32 g/dl, P = 1.00), and women on ferrous sulfate arm had an increase in Hb: 1.1 g/dl (95% CI, 0.83 to 1.37 g/dl, P < 0.0001).Women on 200 mg bLf had an increase in ferritin: 2.8 μg/l (95% CI, 0.38 to 5.22 μg/l, P = 0.02), women on 400 mg bLf had an increase in ferritin: 3.5 μg/l (95% CI, 0.64 to 6.36 μg/l, P = 0.02) and women on ferrous sulfate arm had an increase in ferritin: 41.1 μg/l (95% CI, 35.74 to 46.47 μg/l, P < 0.0001).There were no significant differences in AGP and CRP between arms at the base line (P = 0.38 and 0.95) and end line (P = 0.87 and 0.14). Those on ferrous sulfate had a significant increase in hepcidin concentration after 90 days (P = .000).Abdominal pain, indigestion, diarrhea and black stool were significantly higher on ferrous sulfate group. There were no differences for other side-effects across treatment arms ConclusionsFerrous sulfate has better efficacy than bLf for iron deficiency anemia in non-pregnant non-lactating women of reproductive age in urban Bangladesh. This lactoferrin product may be inactive, or there may have been inadequate dietary iron for bLF to promote its absorption. Funding SourcesSaving Lives at Birth and Medical Research Council, UK.

Iron Oxide Nanoparticles Versus Ferrous Sulfate In Treatment of Iron Deficiency Anemia In Rats

Ferrous sulfate is the most commonly used drug for treatment of iron deficiency anemia, but it is badly absorbed and causes many unfavorable side effects. Nanotechnology is a way to decrease the side effects of drugs and to increase the drug bioavailability. So, this study is designed to investigate the effect of iron oxide nanoparticles in comparison to ferrous sulphate in the treatment of iron deficiency anemia in rats. Forty male albino rats were divided into two main groups: Control group (10 rats) and anemic group (30 rats) that received standard iron free basal diet for six weeks. Then the anemic group was subdivided into three groups (10 rats) in each group: anemic control group, ferrous sulfate group (received ferrous sulfate 0.4 mg/kg b.w/ 10 days) and iron oxide nanoparticles group (received iron oxide nanoparticles 0.4 mg/kg b.w/ 10 days) in the drinking water. Iron oxide nanoparticlescaused a significant increase in the level of red blood cells (8.80±0.05 106/µL), hemoglobin (18.46±0.33 g/dL), hematocrit (46.66±0.23 %), mean corpuscular volume (MCV) (53.02±0.3 FL), mean corpuscular hemoglobin concentration (MCHC) (39.56±0.6 %), ferritin (447.6±9.02 µg/L), transferrin saturation (138.0±1.5), total iron binding capacity (TIBC) (145.00±1.15 mg/dL) and serum iron (276.33±2.07 mg/dL). Moreover, it decreased serum malondialdehyde (MDA) (31.85±0.34 nmol/g) and C-reactive protein (CRP) (312.66±1.7 mg/L) when compared to ferrous sulfate group and anemia control groups. These results revealed that iron oxide nanoparticles proved as an effective drug for the treatment of iron deficiency anemia in rats.

Efficacy and safety of ferric carboxymaltose versus ferrous sulfate for iron deficiency anemia during pregnancy: subgroup analysis of Korean women

BackgroundWe performed a post-hoc subgroup analysis in Korean women who participated in the Phase III FER-ASAP (FERric carboxymaltose-Assessment of SAfety and efficacy in Pregnancy) study to compare the efficacy and safety of ferric carboxymaltose (FCM) with oral ferrous sulfate (FS).MethodsPregnant Korean women (gestational weeks 16–33) with iron-deficiency anemia (IDA) were randomized 1:1 to FCM (n = 46; 1000–1500 mg iron) or FS (n = 44; 200 mg iron/day) group for 12 weeks. The primary objective was to compare the mean hemoglobin (Hb) increase at week 3; secondary objectives included change in iron parameters, quality of life (QoL), and safety.ResultsBaseline characteristics of the Korean subgroup were consistent with those of non-Korean FER-ASAP population except for lower body-mass index and higher maternal age. Hb level increases were comparable between the two treatment groups in Korean women at week 3 (FCM 1.23 ± 0.89 g/dL vs FS 1.14 ± 1.72 g/dL). Iron parameters improved over time as secondary endpoints were significantly in favor of FCM. In terms of QoL, FCM treatment significantly improved the mental and physical components as well as vitality prior to delivery. Both treatments were well tolerated.ConclusionsFCM provided significantly greater improvements in iron parameters and QoL compared to FS in the Korean subgroup. FCM may be a preferable alternative to currently available treatments for IDA during pregnancy.

Efficacy of ferrous bis-glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia with pregnancy: a randomized double-blind clinical trial

Objective: The aim of this study is to compare the efficacy and tolerability of oral ferrous bis-glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia (IDA) with pregnancy. Methods: A randomized double-blind clinical trial (NCT02590224) conducted at a tertiary University Hospital in the period between 1 January 2016 and 31 July 2017 included pregnant women at 14–18 weeks of gestation with mild to moderate IDA. Patients were randomized into two groups: (Group I) received oral ferrous bis-glycinate tablets once daily for eight consecutive weeks and (Group II) received oral ferrous glycine sulfate capsules in the same dose and duration. The primary outcome of the study was the rate of increase of hemoglobin (HB) level after 8 weeks of iron treatment. Results: The study included 187 women in the final analysis. The mean increase in HB level after 8 weeks of treatment in ferrous bis-glycinate group was 2.48 ± 0.12 g/dL versus 1.32 ± 0.18 g/dL in ferrous glycine sulfate group (p ≤ .0001). The percentage of women with HB level more than 11 g/dL after 8 weeks of treatment was 89.2% in ferrous bis-glycinate group versus 71.3% in ferrous glycine sulfate group (p < .0001). The rate of adverse effects was significantly higher in ferrous glycine sulfate group (p = .001). Conclusions: Pregnant women with second trimester IDA could be supplied with ferrous bis-glycinate which is more efficient in increasing HB level. Moreover, it has tolerable adverse effects and high compliance than ferrous glycine sulfate.

IRON DEFICIENCY ANEMIA

Objective: To compare the efficacy of Ferrous sulfate with iron polymaltosecomplex in treatment of iron deficiency anemia in children in terms of rise in hemoglobin. Studydesign: Randomized clinical trial. Setting: Department of Paediatric Medicine Unit I AlliedHospital Faisalabad. Study duration: 6 months. Methodology: All the children of age group6 month to 12year with hemoglobin level &lt;10g/dl, MCV&lt;70fl corrected for age, MCHC&lt;32%,serum ferritin&lt;8μg/l were included. All other cases of anemia other than iron deficiency anemiasuch as thalassemia, sickle cell anemia, lead poisoning etc, patients with severe anemia(hb≤6g/dl) because they need blood transfusion to correct anemia, those with decompensatedheart failure or acute infection were excluded. After enrolment patients were randomly dividedinto two groups by lottery method. Group A, patients were given ferrous sulphate. Group B,patients were given iron polymaltose complex (IPC). Both iron preparations were given inthe dose of 5mg/kg/day of elemental iron in three divided dosage 30 minutes before meals.Patients were assessed at one month interval after the start of treatment and hemoglobin waschecked at follow up visit by taking 2cc blood. Results: Sixty children were studied. Meanage was 2.5 ± 5.1 years, range 7 months to 12 years with 32 girls, 28 boys. The patients wereevenly distributed between the two treatment groups (IPC, n = 30, 50%; ferrous sulfate, n =30, 50%). All erythrocyte-related hematologic parameters after one month treatment showed asignificant improvement from baseline with both treatments. A significant improvement in Hbwas observed after one month treatment in the IPC group 9.5 ± 1.1g/dL to 10.6 ±1.0 g/dL andthe ferrous sulfate group 9.4 ± 1.6 g/dL to 11.2 ± 0.9 g/dL which was statistically significant.Conclusion: From this randomized study, it is concluded that both ferrous sulphate and ironpolymaltose complex have equal efficacy in treatment of iron deficiency anemia

Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia

Iron-deficiency anemia (IDA) affects millions of persons worldwide, and is associated with impaired neurodevelopment in infants and children. Ferrous sulfate is the most commonly prescribed oral iron despite iron polysaccharide complex possibly being better tolerated. To compare the effect of ferrous sulfate with iron polysaccharide complex on hemoglobin concentration in infants and children with nutritional IDA. Double-blind, superiority randomized clinical trial of infants and children aged 9 to 48 months with nutritional IDA (assessed by history and laboratory criteria) that was conducted in an outpatient hematology clinic at a US tertiary care hospital from September 2013 through November 2015; 12-week follow-up ended in January 2016. Three mg/kg of elemental iron once daily as either ferrous sulfate drops or iron polysaccharide complex drops for 12 weeks. Primary outcome was change in hemoglobin over 12 weeks. Secondary outcomes included complete resolution of IDA (defined as hemoglobin concentration >11 g/dL, mean corpuscular volume >70 fL, reticulocyte hemoglobin equivalent >25 pg, serum ferritin level >15 ng/mL, and total iron-binding capacity <425 μg/dL at the 12-week visit), changes in serum ferritin level and total iron-binding capacity, adverse effects. Of 80 randomized infants and children (median age, 22 months; 55% male; 61% Hispanic white; 40 per group), 59 completed the trial (28 [70%] in ferrous sulfate group; 31 [78%] in iron polysaccharide complex group). From baseline to 12 weeks, mean hemoglobin increased from 7.9 to 11.9 g/dL (ferrous sulfate group) vs 7.7 to 11.1 g/dL (iron complex group), a greater difference of 1.0 g/dL (95% CI, 0.4 to 1.6 g/dL; P < .001) with ferrous sulfate (based on a linear mixed model). Proportion with a complete resolution of IDA was higher in the ferrous sulfate group (29% vs 6%; P = .04). Median serum ferritin level increased from 3.0 to 15.6 ng/mL (ferrous sulfate) vs 2.0 to 7.5 ng/mL (iron complex) over 12 weeks, a greater difference of 10.2 ng/mL (95% CI, 6.2 to 14.1 ng/mL; P < .001) with ferrous sulfate. Mean total iron-binding capacity decreased from 501 to 389 μg/dL (ferrous sulfate) vs 506 to 417 μg/dL (iron complex) (a greater difference of -50 μg/dL [95% CI, -86 to -14 μg/dL] with ferrous sulfate; P < .001). There were more reports of diarrhea in the iron complex group than in the ferrous sulfate group (58% vs 35%, respectively; P = .04). Among infants and children aged 9 to 48 months with nutritional iron-deficiency anemia, ferrous sulfate compared with iron polysaccharide complex resulted in a greater increase in hemoglobin concentration at 12 weeks. Once daily, low-dose ferrous sulfate should be considered for children with nutritional iron-deficiency anemia. clinicaltrials.gov Identifier: NCT01904864.

A double-blind, randomized, and active-controlled phase III study of Herbiron drink in the treatment of iron-deficiency anemia in premenopausal females in Taiwan

BackgroundAbout 468 million non-pregnant women are estimated to suffer from iron-deficiency anemia (IDA) worldwide. The highest prevalence of IDA occurs in the Taiwanese population.ObjectiveTo evaluate the effectiveness of Herbiron to increase iron absorption in women with IDA.DesignPhase III double-blind, randomized, active-controlled, and parallel comparative study enrolled 124 patients with IDA and consisted of a 2-week run-in period, randomization, 12 weeks of supplementation, and 4 weeks of follow-up. The treatment group received Herbiron drink 50 mL p.o., b.i.d., before meals (daily iron intake: 21 mg/day) plus placebo tablets. The control group received a ferrous sulfate tablet, t.i.d., plus placebo 50-mL drink before meals (daily iron intake: 195 mg/day).ResultsBoth treatments significantly improved hemoglobin and all secondary efficacy endpoints. Most IDA patients treated with Herbiron or ferrous sulfate finished the study in the normal range. Ferrous sulfate treatment induced a rapid rate of hemoglobin synthesis, which plateaued by week 8, whereas Herbiron treatment increased the rate of hemoglobin synthesis more slowly, likely due to its nine-fold lower iron content. Gastrointestinal adverse events (diarrhea, abdominal pain, dyspepsia, and nausea) but not infectious adverse events were significantly more common in the ferrous sulfate group (n=11, 18.3%) than those in the Herbiron group (n=1, 1.6%) (p=0.004).ConclusionTwelve weeks of Herbiron treatment delivering 21mg of iron or ferrous sulfate treatment delivering 195 mg of iron induced normal hemoglobin levels in 62 or 91% of non-pregnant women with IDA in Taiwan, respectively, suggesting dose-dependent and bioavailability effects.

Effects of Fe-YM1504 on iron deficiency anemia in rats.

Iron deficiency anemia (IDA) is one of the most serious forms of malnutrition. It is possible that some strains present in the natural environment possess a higher tolerance to inorganic iron and a higher ability to convert and accumulate iron compared with Saccharomyces cerevisiae wild-type strain. In the present study, the strain no. YM1504, able to grow in an iron-rich environment, was used as a potential organic iron supplement, and its efficacy in alleviating IDA in rats was investigated. Sixty female weanling Sprague-Dawley rats were randomly divided into a normal control group fed with a standard diet and a model group fed with an iron-deficient diet to create the IDA model. After the model was established, IDA rats were further randomly divided into five subgroups: the IDA group, the ferrous sulfate (FeSO4) group and Fe-YM1504 low-, medium- or high-dose groups receiving different concentrations of Fe-YM1504 supplements. Our results showed that Fe-YM1504 has an effective restorative function by returning the hemoglobin (Hb), hematocrit (HCT), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), serum iron (SI), total iron binding capacity (TIBC), serum ferritin (SF), etc. in IDA animals to the normal level. Moreover, malondialdehyde and the enzyme activities of superoxide dismutase and glutathione peroxidase in both plasma and liver homogenate were improved. Finally, compared with the FeSO4 group, the Fe-YM1504 middle-dose was more effective in alleviating IDA and fewer side effects were observed. The present study indicated that iron-enriched strain no. YM1504 might play a significant role in ameliorating IDA rats and might be exploited as a new iron supplement.