Hydroxide Polymaltose Complex Research Articles

Oral Iron-Hydroxide Polymaltose Complex Versus Sucrosomial Iron for Children with Iron Deficiency with or without Anemia: A Clinical Trial with Emphasis on Intestinal Inflammation.

Iron deficiency anemia (IDA) is a major public health problem among children worldwide. Iron deficiency without anemia (IDWA) is at least twice as common as IDA. Some studies propose that oral iron fortification can modify the infant's gut microbiome, leading to intestinal inflammation. To determine whether oral iron therapy can lead to intestinal inflammation in children with IDA or IDWA. Fifty-six patients aged 6 months to 16 years (median age 7.6 years) with IDA or IDWA were randomly assigned to receive either iron (III)-hydroxide polymaltose complex (IPC) 5 mg/kg once daily (maximum dose 100 mg) or sucrosomial iron (SI)1.4 mg/kg once daily (maximum dose 29.4 mg). Safety and efficacy were studied after 30 and 90 days of treatment. In addition, fecal calprotectin as a marker of intestinal inflammation was measured simultaneously and compared to results obtained before therapy. A significant increase in serum ferritin was noted in both groups as the median ferritin level at baseline was 6.7 μg/L in the IPC group and 6.6 μg/L in the SI group, increasing to 15.9 μg/L and 12.1 μg/L respectively, after 90 days of treatment. However, there was no significant change in fecal calprotectin in either group. In addition, no differences in the trend over time were observed between the two groups regarding fecal calprotectin, serum ferritin, and hemoglobin. IPC and SI were equally effective in treating IDA and IDWA. At the recommended doses, oral iron therapy does not seem to induce intestinal inflammation.

Pica sebagai Manifestasi Anemia Defisiensi Besi: Suatu Laporan Kasus

Prevalence of anemia in Indonesia based on Basic Health Research (2018) was 23.7%. Symptoms of iron deficiency anemia were pallor, malaise, palpitation, shortness of breath, headache, sore tongue. But sometimes can be found abnormal behavior in the form of PICA. This article reports on a-52-year-old man who sought medical treatment and was diagnosed with iron deficiency anemia with pica manifestation. The pica manifestation was characterized by a repeated desire to consume raw rice due to bleeding from hemorrhoids. Patient was given oral iron replacement therapy contain 100 mg of Fe (III) hydroxide polymaltose complex and folic acid 0.35 mg alternating with vitamin C 500 mg daily. Total iron daily dose given were 200 mg, divided in two doses. The patient received dietary education and was advised to consult a Gastroenterohepatology Subspecialist for the management of hemorrhoids, but it has not been done yet. The desire for raw rice consumption disappeared and the hemoglobin level increased to 12.4 g/dL after six weeks of therapy. The patient continued to take iron supplements until January 2023 but did not have follow-up visits to the clinic. In January 2023, the patient underwent hemorrhoid surgery due to bleeding accompanied by and a non-reducible lump that had been present for three days. Iron supplements continued for one month post-operation and then discontinued. The latest hemoglobin level was 15.3 g/dL without iron supplements. The symptoms of pica in this patient disappeared along with an increased hemoglobin level, and the management of severe anemia in this patient showed an adequate response. Bleeding has never occurred again after the surgery. Curative measures for hemorrhoidal bleeding are crucial, while iron supplementation is only a supportive therapy.

Results of Randomized Comparative Efficacy Study of Iron Deficiency Anemia Management in Children with Iron III Hydroxide Polymaltose Complex and Iron Sulfate

Background. The guidelines on selection between iron preparations, iron sulfate (IS) and iron III hydroxide polymaltose complex (HPC), for iron deficiency anemia (IDA) management in pediatrics are contradictory. Objective. The aim of the study is to compare efficacy and safety of iron (III) HPC and IS for IDA treatment in children. Materials and methods. Randomization of children (aged from 1 month to 18 years) with IDA into 2 therapeutic groups was implemented in 2019-2020. on pediatric districts of children’s city outpatient's clinic: IS dosage of 3 mg/kg/day and iron (III) HPC dosage of 5 mg/kg/day. Hemogram monitoring was performed every 14 days. The efficacy was compared according to the rate of Hb level increase, erythrocytes indices, and serum ferritin (SF) level at the recorded moment of Hb normalization. For the safety — the rate of adverse effects. Results. 65 children with IDA were included in the study and randomized into 2 groups, the median age was 2.3 years (1st; 3rd quartile = 1.1; 4.3). Hb level increase was comparable in both groups (0.34 (0.23; 0.48) g/L/day and 0.24 (0.21; 0.30) g/L/day, р = 0.891). IS is more effective than iron (III) HPC in terms of average red blood cell volume by the time of Hb normalization (83.5 (80.0; 86.7) fl against 80.7 (79.0; 82.0) fl, р = 0.006), and mean cellular hemoglobin content (28.9 (SD = 2.0) pg against 27.4 (SD = 1.8) pg, р = 0.004). The timing of SF levels normalization did not differ. Adverse effects to iron III HPC treatment occurred 5.5 times more frequently than to IS (p = 0.0001). Conclusion. The efficacy of IS and iron III HPC at standard doses is comparable. The advantage in tolerability and recovery of erythrocytic indices justifies the feasibility of using IS preparations in the first line of treatment for children with IDA.

Iron Supplementation in Anemic Pregnant Women: A Comparison of Different Prescription Options in Pakistan

Background & objectives: Many pregnant women in Pakistan have iron deficiency anemia (IDA), a dietary deficit. It affects both the mother's and the foetal' health. Oral iron supplementation usually relieves IDA symptoms. Oral iron supplements are hazardous to the GI mucosa, and sensitivity is common. Poor therapeutic compliance leads to treatment failure. Ferrous ascorbate (FeA) and iron hydroxide polymaltose complex (IPC) reportedly improve gastrointestinal discomfort and increase patient compliance compared to ferrous sulphate (FS). These preparations reportedly improve hemoglobin levels and iron stores more quickly than FS. This analysis compared FS's efficacy and safety to IPC and FeA. Place of Study: Rashid Latif Medical College Lahore Duration of Study: February 2019 and October 2021 Methods: It was a randomized, parallel, open label, investigation among pregnant women of gestational age from 10 to 28 weeks with moderate anemia. Patients were randomly selected to receive either FS, IPC or FeA. They were then followed up for 3 months to look for improvement in the hemoglobin levels and other hematological indicators or any adverse drug response. Results: With the exception of 3 months, when the FeA group had a significantly higher hemoglobin level in comparison to the FS group (P <0.05), the hemoglobin levels were comparable across the three groups. The overall risk profiles for side effects were likewise equal across the research groups, with the exception of epigastric discomfort, which was more frequently reported in the FS group. Conclusions: The findings of the study indicated that FS, IPC, and FeA all have an efficacy and safety profile in the treatment of IDA associated with pregnancy that is comparable to one another. Keywords Anemia, ferrous ascorbate , ferrous sulphate ,iron hydroxide polymaltose ,pregnancy

EFFECT OF IRON (III)-HYDROXIDE POLYMALTOSE COMPLEX ON ANEMIA: A LITERATURE STUDY

Health is an important thing to be maintained in life. In the development of this era, many people, especially teenagers, do not pay attention to the intake of nutrients, iron, and protein that enter the body causing disease. One of the diseases that can be caused is anemia. According to the National Institute of Health (NIH) the cause of anemia can be caused by a lack of iron, vitamins, or chronic disease. In Indonesia, the occurence of anemia is fairly high. still quite high. To overcome anemia, iron complex compounds can be used because one of the things that causes anemia is a lack of iron in the body. This study aims to describe the application of iron (III)-hydroxide polymaltose complex as an effective compound in overcoming of iron deficiency anemia.This study was compiled from the online literature of local and international journals using secondary data that had been screened based on keywords. The results of the study concluded that iron (III)-Hydroxide Polymaltose Complex Compounds can be used to treat anemia.This literature study covers recently published (year > 2000) reports on iron (III)-Hydroxide Polymaltose Complex Compounds in overcoming the health problem of anemia.

Use of oral iron in managing iron deficiency anemia in children with intestinal failure

Background & ObjectivesAs intestinal failure (IF) inhibits the digestive system from absorbing nutrients, total parenteral nutrition (TPN) is required to provide all of a person's nutritional demands. In children with malabsorptive conditions like IF, iron deficiency anemia (IDA) is common. This study used a quasi-experimental approach to assess the efficacy and safety of oral iron therapy in treating IDA in TPN-dependent children with IF. Materials and MethodsSixteen pediatric patients with an ongoing history of IF, TPN dependency, and iron deficiency anemia were enrolled and given an oral iron syrup dose of ferric hydroxide polymaltose complex (6 mg/kg/day in 2–3 separate doses of elemental iron) after receiving ethical approval and parental consent. Blood tests were done to measure serum iron, ferritin, complete iron-binding capacity [TIBC], transferrin saturation [TSAT], and hemoglobin (Hb) level at the time of inclusion (T0), 14 (T14), and 30 days after treatment (T30). ResultsThe mean age was 7.13 (±1.99) and female were 12 (75%). No remarkable change in Hb level was noted in the first and second subsequent follow-ups, notwithstanding, the normal estimation of the serum ferritin level significantly increased during the first follow-up (on fourteenth day) which further enhanced by second follow-up (30th day). The aggregate of the total iron binding capacity (TIBC) declined during the course of oral iron therapy with a reduction in transferrin saturation. Interpretation & ConclusionThe data suggest that oral iron therapy is unsuccessful in the treatment of IDA in children with IF. There is no substantial improvement in hemoglobin level or iron profile aside from serum ferritin. In order to avoid using parenteral iron in IF patients, an additional supportive system is needed to aid in the integration of oral iron therapy.

Protective effect of Beta vulgaris roots supplementation on anemic phenylhydrazine-intoxicated rats.

Anemia is a public health problem that affects many people worldwide. Beetroot (Beta vulgaris) is a plant supposed to have many healthy features. The present study was done to evaluate the anti-anemic effect of beetroot supplement on anemia induced by phenylhydrazine in albino rats. Fifty rats were randomly divided into five equal groups. The control group was kept normal rats. In the second group, anemia was induced in rats by intraperitoneal injection of phenylhydrazine at 60 mg/kg in 3 divided doses daily, for 3 consecutive days. The last three groups received phenylhydrazine as the anemic group. Then, the third group received beetroot extract in dose 200 mg/kg for 24 days. The fourth group received beetroot powder in dose 1000 mg/kg for 24 days. The last group received iron (III) hydroxide polymaltose complex in dose 5mg/kg for 24 days. Our results showed that hemolytic anemia induced by phenylhydrazine in rats caused alteration in the blood picture, iron indices, serum biochemical parameters, antioxidant biomarkers, and histopathological picture. However, the supplementation with beetroot ameliorated these alterations, especially beetroot powder which showed powerful health effects compared to beetroot extract and iron preparation.

Lactoferrin versus iron hydroxide polymaltose complex for the treatment of iron deficiency anemia in children with cerebral palsy: a randomized controlled trial.

Iron deficiency anemia (IDA) is common among children with cerebral palsy (CP), and studies on the efficacy of lactoferrin (Lf) in the treatment of IDA are limited. This study aimed to compare the efficacy of Lf with that of iron hydroxide polymaltose complex (IPC) in the treatment of IDA in children with CP. This randomized controlled study, conducted at Alexandria University Children's Hospital, enrolled 70 children aged 1-10 years with CP and IDA; 35 children randomly received IPC, whereas the other 35 received Lf. Four children withdrew from the study; thus, only 66 children were analyzed (32 in the IPC group and 34 in the Lf group). At baseline, the hemoglobin level and other blood parameters were similar between the two intervention groups. After four weeks of treatment, both the IPC and Lf groups showed significant improvements in hemoglobin (Hb), serum ferritin (SF), serum iron, total iron-binding capacity, mean corpuscular volume, and mean corpuscular hemoglobin from baseline. Upon comparing the two treatment groups, adjusted mean Hb and SF changes in the Lf group were significantly higher than that of the IPC group (p =0.001and p= 0.033, respectively), and constipation was less likely to occur in the Lf group than the IPC group (p = 0.049 ).Conclusion: Lactoferrin is effective and superior to IPC as an oral iron replacement therapy in children with CP and IDA, as it has fewer side effects. What is Known: • Lactoferrin (LF) is a natural glycoprotein capable of treating iron deficiency anemia (IDA). • Studies on the efficacy of Lf in the treatment of IDA in children with cerebral palsy (CP) are limited. What is New? • This trial compared the efficacy of Lf and iron hydroxide polymaltose complex (IPC) as treatments of IDA in children with CP. • Lf is effective and even better than IPC as a treatment of IDA in children with CP, as it has fewer side effects.

Interventions for treating iron deficiency anaemia in inflammatory bowel disease.

Interventions for treating iron deficiency anaemia in inflammatory bowel disease.

Частота и причины железодефицита у малочисленных народов Севера (ханты и манси), мигрировавших в город и ведущих традиционный образ жизни (стойбища, село), опыт применения препаратов железа

Objective. To study the health status of women from among the small-numbered indigenous peoples of the North (SIPN), including those leading a traditional way of life in camps and rural areas. Patients and methods. Using continuous sampling method, a prospective analysis of complaints, anamnestic, anthropometric, and laboratory data was carried out in female patients from among SIPN (Khanty and Mansi) living in rural areas and camps, as well as in the city of Khanty-Mansiysk. The comparison group consisted of women from the migrant population (Russians) living in the city of Khanty-Mansiysk. Results. The greatest number of health disorders was found among SIPN who migrated to the city in the first and second generations. Overweight was observed in 46.2% of women in this cohort, obesity was diagnosed in 19.2% of women. Heavy and prolonged menstrual bleeding was the main cause of iron deficiency (11.5%) and iron deficiency anemia (IDA) (30.8%) in the group of SIPN living in the city. IDA of mild severity occurred in 19.2% of patients, and of moderate severity – in 11.5%. Conclusion. Iron metabolism disorders were observed in 42.3% of women from among SIPN who migrated to the city. Iron(III)- hydroxide polymaltose complex (Ferrum Lek®), which is used in the complex therapy of gynecological diseases (menstrual disorders) and gastrointestinal diseases, has high efficiency, good tolerability and the least number of adverse effects. This makes it possible to recommend it for the treatment of IDA and for the replenishment of iron stores in women in both SIPN and newcomer populations. Key words: anemia, iron deficiency, female residents of the Khanty-Mansi Autonomous Area-Yugra, small-numbered indigenous peoples of the North (Khanty and Mansi), Ferrum Lek

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.

Пероральная пролонгированная форма препарата железа для лечения железодефицитной анемии: клинический разбор и фармакоэкономическая оценка

Iron-deficiency anemia (IDA) is an important issue. The prevalence of IDA in women of reproductive age and women in perimenopause is high and has no tendency to reduce. Pharmacoeconomic aspects and recent data on clinical efficacy of iron supplements for obstetrical gy-necological disorders are addressed. The authors review international and domestic published data on iron supplements prescribed in women with obstetrical gynecological diseases. The paper describes the results of cost-effectiveness analysis and clinical trials published earlier that compare the efficacy of the treatment with iron supplements in women who experienced IDA or gynecological disorders complicated by iron deficiency during the pregnancy. One of the bivalent iron retard preparations, Tardyferon®, is discussed. In addition, Tardyferon® is compared with similar iron supplements and Fe(III)-hydroxide-polymaltose complex. Pharmacoeconomic utility of bivalent iron preparation from the viewpoint of the patient and the doctor is validated.Keywords: pharmacoeconomic analysis, iron deficiency, iron-deficiency anemia, pregnancy, iron supplements, bivalent iron.For citation: Dobrokhotova Yu.E., Markova E.A. Peroral retard iron preparation for iron-deficiency anemia: case study and pharmacoecono-mic analysis. Russian Journal of Woman and Child Health. 2020;3(2):88–94. DOI: 10.32364/2618-8430-2020-3-2-88-94.

Анемизирующий синдром у современных женщин — нерешенная мировая проблема. Врачебная тактика

Objective of the Review: To set forth the frequency and prevalence of the anemia syndrome in non-pregnant and pregnant women and approaches to treating this disorder. Key Points: Anemia syndrome is the most common health problem in contemporary women. The leading cause of iron deficiency in women of reproductive age is abnormal uterine bleeding (AUB). Anemia in women significantly reduces their ability to work and quality of life, and increases the rates and severity of complications in pregnant women and parturients. It is also a significant contributor to maternal mortality and fetal and neonatal morbidity. Treating anemia in pregnant women presents certain challenges. In the period between the first trimester and delivery, there is an 8-fold increase in the requirement for iron; therefore, hemoglobin levels return to normal slowly. The active ingredient of Ferrum Lek is a ferric hydroxide polymaltose complex, which is as effective as medications containing ferrous sulfate, but is significantly better tolerated by patients and easier to use. The active transport of iron allows its controlled absorption from the polymaltose complex, minimizing the risk of an increase in serum levels of iron not bound to transferrin. This ensures that this medication is very safe and eliminates the risk of overdose or poisoning. Conclusion: Anemia syndrome is the most common type of homeostatic imbalance in women of reproductive age. It most often results from frequent and abundant uterine bleeding (AUB). Therefore, an obstetrician-gynecologist plays the leading role in identifying menstrual disorders and choosing therapies to reduce blood loss. A gynecologist will also work with an internist (hematologist) in treating iron deficiency anemia. Keywords: anemia syndrome, iron deficiency anemia, abnormal uterine bleeding, ferric hydroxide polymaltose complex.

Effects of 6-months of oral ferrous and ferric supplement therapy in patients who were hospitalized for decompensated chronic heart failure.

ObjectiveAnemia is common in patients with chronic heart failure (CHF). This study aimed to examine the frequency of iron deficiency anemia in patients with CHF. We investigated the effects of oral ferrous or ferric supplementation on prognosis of CHF and quality of life.MethodsA total of 201 patients with chronic decompensated heart failure were enrolled in a 6-month prospective study. Patients were randomly assigned to two groups. Patients in group I (n = 100) received ferrous fumarate and those in group II (n = 101) received ferric hydroxide polymaltose complex. Quality of life was measured by the 6-minute walking test (6MWT).ResultsA total of 49% of the patients had iron-dependent anemia in group I and 53.3% were anemic in group II. In group I, the number of anemic patients was significantly lower at 6 months after admission compared with at initial admission (49% versus 45%). Significant improvements were observed in hemoglobin values, the 6MWT distance, and New York Heart Association class after 6 months in both groups.ConclusionsIron deficiency is a significant comorbidity in CHF, even without anemia. Iron should be replaced orally or intravenously because it significantly improves the quality of life of patients.

Determination of Nickel and Manganese Contaminants in Pharmaceutical Iron Supplements Using Energy Dispersive X-ray Fluorescence.

In this study, we investigate the capability of energy dispersive X-ray fluorescence (EDXF) spectrometry in a triaxial geometry apparatus as a fast and nondestructive determination method of both dominant and contaminant elements in pharmaceutical iron supplements. The following iron supplements brands with their respective active ingredients were analyzed: Neutrofer fólico (iron gylcinate), Anemifer (iron(II) sulfate monohydrate), Noripurum (iron(III)-hydroxide polymaltose complex), Sulferbel (iron(II) sulfate monohydrate), and Combiron Fólico (carbonyl iron). Although we observe a good agreement between the iron content obtained by the present method and that indicated in the supplement's prescribed dose, we observe contamination by manganese and nickel of up to 180 μg and 36 μg, respectively. These contents correspond to 7.2% and 14.4% of the permitted daily exposure of manganese and nickel, respectively, for an average adult individual as determined by the European Medicine Agency (EMEA). The method was successfully validated against the concentrations of several certified reference materials of biological light matrices with similar concentrations of contaminants. Moreover, we also validated our method by comparing the concentrations with those obtained with the inductively coupled plasma-atomic emission technique.

Результаты рандомизированного исследования лечения железодефицитной анемии у детей и подростков с помощью железа (III) гидроксид полимальтозного комплекса и сульфата железа: критерии эффективности и переносимость

Результаты рандомизированного исследования лечения железодефицитной анемии у детей и подростков с помощью железа (III) гидроксид полимальтозного комплекса и сульфата железа: критерии эффективности и переносимость

The Efficacy of Trivalent Ferrum Early Application for Prevention of Anaemia in Preterm Infants. International Experience Review.

Studies have been performed to determine the efficacy of early application of trivalent ferrum in the form of iron(III)-hydroxide polymaltose complex (IPC Fe3+) for anaemia prophylaxis in preterm infants. The proposed prophylaxis contributes to more rapid stabilization of haematological parameters, and reduces the need for blood transfusions.

NEWBORN CHILDREN AND IRON DEFICIENCY STATES: NEONATOLOGist’s view (Clinical lecture)

Modern views on development of iron deficiency states in newborn children are given in article. The main clinical characteristics of iron deficiency states, the principles of their diagnostics, prevention and treatment by hydroxide-polymaltose complex of the trivalent iron in drops were submitted.

Ferrous Sulfate (Fe2+) Had a Faster Effect Than Did Ferric Polymaltose (Fe3+) on Increased Oxidant Status in Children With Iron-deficiency Anemia

The purpose of this study was to compare the total oxidant and antioxidant effect of different oral iron preparations in children with iron-deficiency anemia (IDA). A total of 65 children with IDA were randomized to receive 5 mg Fe/kg/d iron (II) sulfate (Fe(2+) group, n=33) or iron (III)-hydroxide polymaltose complex (Fe(3+) group, n=32); healthy controls (n=28) were also included in the study. Serum total thiol (-SH), total antioxidant capacity (TAC), total oxidant status (TOS), oxidative stress index (OSI), and hematological profile were evaluated at the baseline and on day 8 and day 30 of the therapy. Serum TOS and OSI levels were significantly higher and total -SH and total antioxidant capacity levels were significantly lower in the study groups at the beginning of therapy than in the controls (P>0.001). In multivariate analysis, after controlling for multiple confounding factors, on days 8 and 30, serum TOS and OSI levels were not different in the Fe(3+) group, whereas they were significantly reduced in the Fe(2+) group (P≤0.033). Serum total oxidant status was significantly increased in children with IDA, and Fe(2+) was highly effective in correcting elevated oxidative status.

Effects of iron therapy on blood lead concentrations in infants

To determine whether blood lead concentration is elevated in iron-deficient infants, blood lead and serum ferritin concentrations, serum iron/transferring iron-binding capacity (Fe/TIBC) and complete blood counts were measured in 30 iron deficient and 35 control infants, aged 6–24 months. All 30 iron-deficient infants received iron supplementation (ferric hydroxide-polymaltose complex, 6mg/kg Fe3+/day) for 1–6 months. Blood lead concentrations were measured in 18 of the iron deficient infants after their ferritin levels returned to the normal range. The geometric mean blood lead concentration was higher in iron deficient than in control infants (1.846 vs. 1.416μg/dL). After iron therapy, the blood lead levels of iron-deficient infants decreased significantly compared with pre-treatment levels (1.785 vs. 2.386μg/dL), and the hemoglobin and ferritin concentrations increased significantly. These findings indicate that iron deficiency increases blood lead concentrations in infants with very low blood lead concentrations.