teferrol and ferrous-sulfate

Various therapeutic iron preparations are available in the market, which differ in their pharmacokinetic and safety profiles. There is insufficient evidence regarding the superior safety or efficacy of one over the other.. To study the effects of iron preparations on various parameters like hemoglobin, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and serum ferritin.. A systematic review and meta-analysis of randomized controlled trials (RCT) was conducted from inception till 3 June, 2022.. Databases like MEDLINE and COCHRANE were searched for RCTs evaluating the effects and safety profile of various iron salts in the management of iron deficiency anemia in children and adolescents.. Eight studies with a total of 495 children were included the review. Pooled analysis showed ferrous sulphate to cause a significant increase in hemoglobin compared with other iron compounds [mean difference (95% CI) 0.53 (0.22 to 0.83; P <0.001]. Also ferrous sulphate is superior to iron polymaltose complex (IPC) (P<0.001). However, there was a significant increase in gastrointestinal adverse effects with ferrous sulphate compared to IPC (P=0.03). Other iron compounds were more efficacious than IPC in raising hemoglobin levels (P<0.001). Among the few studies evaluating iron indices like MCV, MCH, and serum ferritin, there was no significant difference between the iron preparations (P>0.05).. A low quality evidence suggests that ferrous sulphate is more efficacious than other compounds (P<0.001); though, there is an increase in gastrointestinal side effects with ferrous sulphate.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Ferritins; Hemoglobins; Humans; Infant; Iron; Iron Compounds

Iron supplementation is required in a preponderance of peritoneal dialysis (PD) patients treated with erythropoietic stimulatory agents (ESAs). Although many authors and clinical practice guidelines recommend primary oral iron supplementation in ESA-treated PD patients, numerous studies have clearly demonstrated that, because of a combination of poor bioavailability of oral iron, gastrointestinal intolerance, and noncompliance, oral iron supplementation is insufficient for maintaining a positive iron balance in these patients over time. Controlled trials have demonstrated that, in iron-deficient and iron-replete PD patients alike, intravenous (IV) iron supplementation results in superior iron stores and hemoglobin levels with fewer side effects than oral iron produces. Careful monitoring of iron stores in patients receiving IV iron supplementation is important in view of conflicting epidemiologic links between IV iron loading and infection and cardiovascular disease. Emerging new iron therapies such as heme iron polypeptide and ferumoxytol may further enhance the tolerability, efficacy, and ease of administration of iron in PD patients.

Topics: Administration, Oral; Clinical Trials as Topic; Darbepoetin alfa; Erythropoietin; Ferric Compounds; Ferritins; Ferrous Compounds; Hemoglobins; Humans; Infusions, Intravenous; Iron; Peritoneal Dialysis; Recombinant Proteins; Transferrin

Iron(III)-hydroxide polymaltose complex (IPC) is an iron preparation with non-ionic iron and polymaltose in a stable complex. The usefulness of IPC in the treatment of iron deficiency anemia (IDA) has recently been a topic of much debate. By reviewing the published literature an overview is provided of the existing comparative evidence vs. ferrous sulfate as reference. For this purpose the standard methods and criteria as described by the Cochrane group are employed. The aim was to establish whether there are differences concerning efficacy (primary end-point: hemoglobin after approx. 2 months of treatment) and concerning safety (number of patients with adverse drug reactions [ADRs]). From an initial group of 14 comparative trials identified, 6 comparative studies (1 double blind) conducted in adults could be retained for analysis. Four pediatric studies initially selected had to be rejected because of heterogeneity of data at baseline. In adults (319 IPC, 238 ferrous sulfate) at the end of the study period (8-13 weeks) the mean hemoglobin values were 12.13 +/- 1.19 g/dl with IPC vs. 11.94 +/- 1.84 g/dl with ferrous sulfate (weighted mean difference WMD = 0.01 [95% CI -0.23, 0.21] g/dl). Not all studies reported on ferremia (higher with IPC), transferrin saturation (no difference) or ferritin (lower with IPC). Adverse drug reactions were reported less frequently with IPC (14.9%) than with ferrous sulfate (34.1%; p < 0.001), particularly upper digestive troubles, stained teeth and diarrhea. The meta-analysis of studies conducted in adult patients with iron deficiency anemia, comparing IPC with ferrous sulfate in equivalent doses, showed that the two compounds attained similar hemoglobin levels, thus suggesting similar efficacy. The tolerance of IPC in adults was clearly better than that of ferrous sulfate; the differences were also significant for the individual adverse reactions. This probably reflects a better risk/benefit ratio of IPC in adults. Properly conducted randomized controlled trials, particularly in pediatrics, are needed.

Topics: Adult; Anemia, Iron-Deficiency; Dietary Supplements; Endpoint Determination; Ferric Compounds; Ferrous Compounds; Humans; Randomized Controlled Trials as Topic; Risk Assessment

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.. 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.. 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.. The results of the study showed that FS, IPC and FeA have comparable efficacy and safety profile in the treatment of IDA of pregnancy.

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Ascorbic Acid; Child; Female; Ferric Compounds; Ferrous Compounds; Humans; Pregnancy; Pregnant Women; Young Adult

The purpose of this study was to compare the effectiveness of different oral iron preparations in children with iron deficiency anemia (IDA).. Sixty children with IDA, aged between 6 months and 180 months, were randomly assigned into three treatment groups. Group I included children with IDA who received ferrous sulfate (Fe-S); Group II included children receiving iron polymaltose complexes (Fe-OH-PM), and Group III included children receiving a single preparation of combined iron and zinc (Fe-Zn). The effect of different iron preparations were evaluated and compared. The duration of treatment was 8 weeks. Hemoglobin (Hgb) levels, as well as other hematological parameters were determined at admission and the first, fourth, and eighth weeks of the treatment.. The Hgb levels of patients in all three groups were statistically higher in the fourth (P=0.001) and eighth (P<0.001) weeks compared to baseline; although there was no difference between the groups at the end of the treatment period (P>0.05).. Our results indicate that, Fe-OH-PM and Fe-Zn preparations may also be preferred as a choice like Fe-S for treatment of children with IDA.

Topics: Administration, Oral; Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Ferrous Compounds; Hematinics; Hemoglobins; Humans; Infant; Male; Treatment Outcome; Zinc

Iron deficiency anaemia (IDA) is the most common nutritional deficiency affecting pregnant women worldwide. This study aims to compare the efficacy and safety of a newly available intravenous (IV) iron preparation, ferric carboxymaltose (FCM), against IV iron polymaltose (IPM), and standard oral iron (ferrous sulphate) for the treatment of IDA in pregnancy. This is an open-labelled prospective randomised controlled trial (RCT) with intention-to-treat analysis conducted at a primary health care facility with a single tertiary referral centre in Launceston. Tasmania, Australia. A 3-arm randomised controlled trial was conducted comparing a single IV infusion of 1000mg of FCM (n = 83 patients) over 15 minutes against a single IV infusion of 1000mg of IPM (n = 82) over 2 hours against 325mg daily oral ferrous sulphate (n = 81) until delivery, for the treatment of IDA in pregnancy. A total of 246 consecutive pregnant women were recruited between September 2013 and July 2014. The median age was 28 years, with a median and mean gestation of 27 weeks. The median serum ferritin was 9µg/L, with a mean of 13µg/L. The mean haemoglobin (Hb) was 114g/L. The primary outcome was the change in ferritin and Hb levels at 4 weeks after intervention. Secondary outcomes included ferritin and Hb improvements at predelivery, safety, tolerability, quality of life (QoL), cost utility, and fetal outcomes. The mean Hb level differences between the baseline intervention time point and 4 weeks thereafter were significantly higher in the FCM versus the oral group by 4.35g/L (95% CI: 1.64-7.05; P = 0.0006) and in the IPM vs the oral group by 4.08g/L (95% CI: 1.57-6.60; P = 0.0005), but not different between the FCM and IPM groups (0.26g/L; 95% CI: -2.59 to 3.11; P = 0.9740). The mean ferritin level differences were significantly higher at 4 weeks in the FCM vs oral iron group by 166µg/L (95% CI: 138-194; P < 0.0001) and in the IPM vs oral iron group by 145µg/L (95% CI: 109-1180, P < 0.0001), but not between the 2 IV groups (21.5µg/L; 95% CI: -23.9 to 66.9; P = 0.4989). Administration of IV FCM during pregnancy was safe and better tolerated than IV IPM or oral iron. Compliance to oral iron was the lowest amongst treatment groups with one-third of the patients missing doses of daily iron tablets. Significant improvement in overall QoL scores was observed in both IV iron supplement groups by achieving normal ferritin following effective and prompt repletion of iron stores, compared to the o

Topics: Administration, Oral; Adolescent; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferrous Compounds; Humans; Infusions, Intravenous; Maltose; Middle Aged; Pregnancy; Prospective Studies; Young Adult

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.

Topics: Anemia, Iron-Deficiency; Antioxidants; Child; Child, Preschool; Delayed-Action Preparations; Female; Ferric Compounds; Ferrous Compounds; Hematinics; Humans; Male; Oxidants; Oxidation-Reduction; Oxidative Stress; Treatment Outcome

In any context of iron supplementation in the prenatal prophylaxis or therapeutic dosage range, a large amount will remain unabsorbed and pass through the intestinal tract into the colonic digesta possibly causing increased oxidation.. To compare the generation of fecal reactive oxygen species (ROS) in situ after daily consumption of 100 mg of elemental iron in three frequently used forms of iron supplements.. Ten healthy, iron-repleted adult males were investigated before and during supplementation with three oral iron compounds: 100 mg of oral iron were given as ferrous sulfate, Na Fe-EDTA and iron polymaltose for 6 days to each subject in an individually stratified sequence. Stool samples were collected and analyzed for iron content and the in situ generation of fecal ROS.. Significant increases in fecal ROS generation were observed during oral iron supplementation. No statistical differences were seen in either residual concentrations of non-heme iron in stool or the level of fecal ROS generation between the three Fe compounds. There was, however, a significant association between the iron concentration in the stool and ROS generation.. In spite of the differences in their chemical characteristics, none of the three distinct iron complexes reduced oxidative stress in the intestinal lumen.

Topics: Adolescent; Adult; Antioxidants; Dietary Supplements; Edetic Acid; Feces; Ferric Compounds; Ferrous Compounds; Hematinics; Humans; Iron; Iron, Dietary; Male; Middle Aged; Oxidants; Oxidative Stress; Reactive Oxygen Species; Young Adult

Oral iron supplementation with ferrous sulfate (FeSO₄) at dosage levels suggested by the international guidelines poses a safety hazard to young children with malaria. Exposure to loosely bound iron in the circulation has been advanced as a potential factor.. To evaluate the kinetics of circulating concentrations of plasma iron and non-transferrin-bound iron (NTBI) in response to oral iron administration in healthy adults.. Plasma samples were collected at 90-minute intervals over a period of 270 minutes from 10 healthy Guatemalan men after oral administration of water or 100 mg of iron from each of three iron compounds: FeSO₄, sodium iron ethylenediaminetetraacetic acid (NaFeEDTA), and iron polymaltose. The four tests were administered in an individually randomized sequence. Serum iron concentration was measured spectrophotometrically by the ferrozine method, and NTBI concentration was measured by a fluorometric competitive binding assay. The kinetic response and the maximal and cumulative changes in circulating concentrations of the biomarkers of interest were compared.. Serum iron and NTBI responses to oral administration of FeSO₄ were significantly greater than responses to plain water or the other two iron compounds. NTBI concentrations after NaFeEDTA or iron polymaltose ingestion were not different from those determined after water intake.. Administration of two iron compounds of proven bioavailability, but with complex absorption characteristics, is associated with a negligible NTBI response, potentially mitigating the safety concerns associated with iron supplementation in malarial areas.

Topics: Adolescent; Adult; Biomarkers; C-Reactive Protein; Dietary Supplements; Edetic Acid; Endemic Diseases; Ferric Compounds; Ferrous Compounds; Food, Fortified; Guatemala; Hemoglobins; Humans; Iron; Kinetics; Malaria, Falciparum; Male; Middle Aged; Risk; Young Adult

To evaluate the efficacy and safety of iron(III) polymaltose complex (Maltofer(®)) versus ferrous sulfate in iron-deficient pregnant women using recommended doses.. An exploratory, open-label, randomized, controlled, multicenter study was undertaken in 80 pregnant women with iron-deficiency anemia (hemoglobin ≤ 10.5 g/dL, serum ferritin ≤ 15 ng/mL and mean corpuscular volume < 80 fL). Patients were randomized 1:1 to oral iron(III) polymaltose complex or ferrous sulfate (each 100 mg iron twice daily) for 90 days.. The primary endpoint, change in hemoglobin from baseline to days 60 and 90, did not differ significantly between treatment groups. The mean (SD) change to day 90 was 2.16 (0.67) g/dL in the iron(III) polymaltose complex group and 1.93 (0.97) g/dL in the ferrous sulfate group (n.s). Mean serum ferritin at day 90 was 179 (38) ng/mL and 157 (34) ng/mL with iron(III) polymaltose complex and ferrous sulfate, respectively (p = 0.014). Adverse events were significantly less frequent in the iron(III) polymaltose group, occurring in 12/41 (29.3%) patients, than in the ferrous sulfate group (22/39 [56.4%]) (p = 0.015).. Oral iron(III) polymaltose complex offers at least equivalent efficacy and a superior safety profile compared to ferrous sulfate for the treatment of iron-deficiency anemia during pregnancy.

Topics: Adult; Anemia, Iron-Deficiency; Erythrocyte Indices; Female; Ferric Compounds; Ferritins; Ferrous Compounds; Gestational Age; Hematocrit; Hemoglobins; Humans; Infant, Newborn; Pregnancy; Pregnancy Complications, Hematologic; Pregnancy Outcome

Iron deficiency anaemia is the most common deficiency disorder in the world, affecting more than one billion people, with pregnant women at particular risk.. We conducted a single site, prospective, nonblinded randomized-controlled trial to compare the efficacy, safety, tolerability and compliance of standard oral daily iron versus intravenous iron.. We prospectively screened 2654 pregnant women between March 2007 and January 2009 with a full blood count and iron studies, of which 461 (18%) had moderate IDA. Two hundred women matched for haemoglobin concentration and serum ferritin level were recruited.. Patients were randomized to daily oral ferrous sulphate 250 mg (elemental iron 80 mg) with or without a single intravenous iron polymaltose infusion.. Prior to delivery, the intravenous plus oral iron arm was superior to the oral iron only arm as measured by the increase in haemoglobin level (mean of 19.5 g/L vs. 12 g/L; P < 0.001); the increase in mean serum ferritin level (222 microg/L vs. 18 ug/L; P < 0.001); and the percentage of mothers with ferritin levels below 30 microg/L (4.5% vs. 79%; P < 0.001). A single dose of intravenous iron polymaltose was well tolerated without significant side effects.. Our data indicate that intravenous iron polymaltose is safe and leads to improved efficacy and iron stores compared to oral iron alone in pregnancy-related IDA.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Birth Weight; Drug Therapy, Combination; Female; Ferric Compounds; Ferritins; Ferrous Compounds; Hematinics; Hemoglobins; Humans; Infant, Newborn; Infusions, Intravenous; Patient Compliance; Pregnancy; Pregnancy Complications, Hematologic; Prospective Studies; Quality of Life; Young Adult

We assessed the clinical response and side effects of Ferrous sulfate (FS) and Iron polymaltose complex (IPC) in 118 children with Iron deficiency anemia (IDA). Subjects were randomized to receive therapy with either oral IPC (Group A, n=59) or oral FS (Group B, n=59); all were given elemental iron in three divided doses of 6 mg/kg/day. One hundred and six children could be followed up; 53 in each group. Children who received ferrous sulfate were having higher hemoglobin level, and less residual complaints as compared to those who had received iron polymaltose complex. Our study suggests ferrous sulfate has a better clinical response and less significant adverse effects during treatment of IDA in children.

Topics: Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Ferrous Compounds; Hemoglobins; Humans; Infant; Male

The efficacy of iron polymaltose complex (IPC) in the treatment of iron deficiency anemia (IDA) during pregnancy has not been well established, and the evidence is inconclusive.. The aim of the study was to compare efficacy, safety, compliance, and cost-effectiveness of IPC with ferrous sulphate (FS) in pregnant patients.. The randomized, double-blind, parallel-group study was conducted in the Department of Pharmacology in collaboration with the Department of Obstetrics and Gynaecology Postgraduate Institute of Medical Education and Research, Chandigarh, India.. One hundred pregnant women aged 20-40 years at 14 to 27 weeks' gestation, with hemoglobin (Hb) < 9 g/dL, and serum ferritin < 12 mcg/L, were classified into 2 groups. One group received IPC (100 mg elemental iron), and the other group received FS (120 mg elemental iron) daily for 8 weeks. At Week 0 and Week 8, Hb, packed cell volume (PCV), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), serum iron, and serum ferritin were measured. Compliance with study medication was determined by pill counting at each visit. Cost minimization analysis was done to compare the costs of the 2 treatments.. Data are expressed as mean -/+ SD. Paired and unpaired 't' test were used to analyze differences within groups and between groups. Chi-square (x2) test was used to analyze primary efficacy parameters and adverse drug reactions (ADR).. Statistically significant increases in Hb, PCV, MCV, MCH, MCHC, serum iron, and serum ferritin levels were seen at the end of 8 weeks of treatment in both groups. The overall adverse effects were more common in the FS group compared with the IPC group [41 (78%) vs 15 (31%), P < .001]. The compliance rate was significantly (P < .05) higher for the IPC (91%) group than for the FS (87%) group. The average total cost (direct + indirect) of treatment of anemia was comparable between the 2 groups.. The results of the present study suggest that IPC can be considered as a useful alternative formulation for the treatment of IDA during pregnancy for those patients who cannot tolerate other iron preparations (ferrous form); this is an important finding, as compliance is a significant concern during pregnancy.

Topics: Adult; Anemia, Iron-Deficiency; Cost-Benefit Analysis; Double-Blind Method; Female; Ferric Compounds; Ferrous Compounds; Humans; Pregnancy; Pregnancy Complications, Hematologic

Iron deficiency is a common complication of inflammatory bowel disease. Oral iron therapy may reinforce intestinal tissue injury by catalyzing production of reactive oxygen species.. To compare the effects of ferrous sulphate and non-ionic iron-polymaltose complex on markers of oxidative tissue damage and clinical disease activity in patients with inflammatory bowel disease.. Forty-one patients with inflammatory bowel disease and iron deficiency were randomized to treatment with ferrous sulphate 100 mg twice a day or iron-polymaltose complex 200 mg once a day for 14 days.. Following ferrous sulphate, plasma malondialdehyde increased (P = 0.02), while urine 8-isoprostaglandin F(2alpha) and plasma antioxidants did not change significantly. Iron-polymaltose complex did not change plasma malondialdehyde, urine 8-isoprostaglandin F(2alpha) or plasma antioxidants. Comparing the two treatments, changes in plasma malondialdehyde tended to differ (P = 0.08), while urine 8-isoprostaglandin F(2alpha) and plasma antioxidants did not differ. Neither ferrous sulphate nor iron-polymaltose complex altered clinical disease activity indices.. Ferrous sulphate increased plasma malondialdehyde, a marker of lipid peroxidation. Comparing treatment with ferrous sulphate and iron-polymaltose complex, changes in plasma malondialdehyde tended to differ. Clinical disease activity was unchanged after both treatments.

Topics: Adolescent; Adult; Aged; Antioxidants; Biomarkers; Dinoprost; Female; Ferric Compounds; Ferrous Compounds; Hematinics; Humans; Inflammatory Bowel Diseases; Iron Deficiencies; Male; Malondialdehyde; Middle Aged; Oxidation-Reduction; Oxidative Stress; Prospective Studies; Reactive Oxygen Species; Tablets; Vasoconstrictor Agents

Absolute iron deficiency is treated by correcting the causative lesion and then, traditionally, administering sufficient amounts of ferrous salt to return the haemoglobin level to normal and replenish body stores. The bioavailability of ferric compounds has been questioned and accordingly their therapeutic role remains controversial. A special problem is posed by regular blood donation, where the frequency of phlebotomy is limited by the haemoglobin level, which, in turn, requires maintenance of an adequate supply of iron from dietary sources. Since this latter situation may not always occur, it would be of practical benefit to have a form of supplementation that is effective and can be taken without side effects. These issues were prospectively examined in a consecutive series of otherwise healthy blood donors who developed absolute iron deficiency anaemia and were then randomly allocated to receive 60 mg of this metal as ferrous sulphate twice a day (Group 1: n = 51), 100 mg as chewable ferric polymaltose daily (Group 2: n = 53), or the latter product twice a day (Group 3: n = 55). Serial studies showed that 80% of patients in Groups 1 and 3 had reached normal haemoglobin levels by 12 weeks, but this figure was only 50% in Group 2. Similarly, the proportion of patients improving their percentage saturation of transferrin to within the normal range was significantly better in Groups 1 and 3 than in Group 2 (P < .01). However, body iron stores, reflected in serum ferritin level, was significantly better in Group 1 (P < .01); there was no difference in this respect between Groups 2 and 3.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Anemia, Hypochromic; Biological Availability; Blood Donors; Female; Ferric Compounds; Ferritins; Ferrous Compounds; Hematinics; Hemoglobins; Humans; Iron; Male; Prospective Studies

The bioavailability of iron on Fe(III)-hydroxide-polymaltose complex was compared intraindividually with that of Fe (II)-ascorbate (iron absorption) and a Fe (II)-sulphate quick release preparation (haemoglobin regeneration test). The study was carried out in a population of 16 healthy male volunteers, phlebotomized in weekly intervals until development of an iron deficiency anaemia in order to establish a test population with only small variations of their individual body iron status. Intestinal iron absorption in fasting state as measured by 59Fe whole body retention and simultaneous estimation from plasma iron tolerance curves was low for the 59Fe (III)-complex (1.2 +/- 0.1% (means +/- SD] as compared to the 59Fe (II)-ascorbate (43.7 +/- 7.1% (means +/- SD]. Iron administration together with a test meal did not affect the absorption from the 59Fe (II)-ascorbate, whereas the 59Fe (III)-complex showed a significant increase in absorption (8.8 +/- 4.7% (means +/- SD]. Haemoglobin (Hb) regeneration after 100 mg of iron as Fe (III)-complex and Fe (II)-sulphate administered during 28 days with meals amounted to a mean of 0.68 +/- 0.2 g/l and 1.1 +/- 0.3 g/l (means +/- SD) of total daily Hb-increase and a net-Hb-increase of 0.31 +/- 0.37 g/l and 0.79 +/- 0.36 g/l (means +/- SD), respectively. There was also a small but significant rise in serum ferritin during the oral treatment in both treatment groups. The results of Hb-regeneration after treatment with the Fe (III)-complex were in the range which could be expected from the absorption measurements.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Anemia, Hypochromic; Ascorbic Acid; Biological Availability; Ferric Compounds; Ferrous Compounds; Food; Humans; Intestinal Absorption; Iron; Iron Radioisotopes; Male

We compared the efficacy of ferrous sulfate (divalent) and ferric polymaltose (trivalent) compounds for the prophylaxis of iron-deficiency anemia (IDA). Study infants included exclusively breast milk-fed term infants. Subjects were divided randomly into 2 groups at 4 months of age and group 1 (n=56) received divalent and group 2 (n=56) received trivalent iron (Fe) preparation at a dose of 2 mg/kg/d for 5 months. At 9 months of age, after a 5-month prophylaxis, a significant increase was observed in hemoglobin (Hb), hematocrit, serum Fe levels, and transferrin saturation in both groups. However, group 1 had significantly higher Hb, hematocrit, mean corpuscular volume, Fe, and transferrin saturation than group 2 (11.7±0.6 g/dL, 34.6%±1.7%, 76.2±2.9 fL, 55.5±1.8 mcg, 20.8±3.9 g/L, respectively in group 1 vs. 11.3±0.5 g/dL, 33.5%±1.5%, 74.7±3.2 fL, 42.5±1.8 mcg, 14.1±7.5 g/L, respectively in group 2). No significant difference was found in ferritin values between the groups. Fe deficiency was found in 17 (30.3%) of the subjects in group 1, and 23 (41%) of subjects in group 2 whereas 5 (8.9%) subjects had IDA in group 1 and 12 (12%) in group 2 which were insignificant between groups. No significant difference was found with regard to side effects between 2 Fe preparations. Although divalent Fe therapy led to a higher Hb and serum Fe level, both ferrous and ferric Fe preparations were effective for prophylactic use in the prevention of Fe deficiency and IDA with comparable side effects.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferritins; Ferrous Compounds; Hemoglobins; Humans; Infant; Premedication; Treatment Outcome

Iron deficiency is common in inflammatory bowel disease, yet oral iron therapy may worsen the disease symptoms and increase systemic and local oxidative stress. The aim of this study was to compare the effects of oral ferrous sulfate and iron polymaltose complex on inflammatory and oxidative stress markers in colitic rats.. Animals were divided into four groups with ten animals each. Rats of three groups received dextran sodium sulfate to induce colitis and animals of two of these groups received 5 mg iron/kg of body weight a day, as ferrous sulfate or iron polymaltose complex, for 7 days. Gross colon anatomy, histology of colon and liver, stainings of L-ferritin, Prussian blue, hepcidin, tumor necrosis factor-α, and interleukin-6, as well serum levels of liver enzymes, inflammatory markers, and iron markers, were assessed.. Body weight, gross anatomy, crypt injury and inflammation scores, inflammatory parameters in liver and colon, as well as serum and liver hepcidin levels were not significantly different between colitic animals without iron treatment and colitic animals treated with iron polymaltose complex. In contrast, ferrous sulfate treatment caused significant worsening of these parameters. As opposed to ferrous sulfate, iron polymaltose complex caused less or no additional oxidative stress in the colon and liver compared to colitic animals without iron treatment.. Iron polymaltose complex had negligible effects on colonic tissue erosion, local or systemic oxidative stress, and local or systemic inflammation, even at high therapeutic doses, and may thus represent a valuable oral treatment of iron deficiency in inflammatory bowel disease.

Topics: Administration, Oral; Animals; Colitis; Dextran Sulfate; Disease Models, Animal; Female; Ferric Compounds; Ferrous Compounds; Hematinics; Inflammation; Male; Oxidative Stress; Rats; Rats, Sprague-Dawley

Although oral iron preparations are widely prescribed to prevent and to treat iron deficiency anemia in pregnancy, comparative data on their effects to the mother, fetus and placenta are limited. In this study, the effects of oral iron polymaltose complex (IPC), ferrous fumarate (FF) and ferrous sulfate (FS) were compared in anemic pregnant rats, their fetuses and placentas. Hematological variables and oxidative stress markers in the liver, heart and kidneys of the dams and fetuses as well as the markers for oxidative stress, inflammation and hypoxia in placentas were assessed. Pregnancy outcome was measured by number of fetuses, and by neonate and placental weight. All therapies were comparably effective in correcting anemia. FS and FF, but not IPC, resulted in liver damage in dams and oxidative stress in dams, fetuses and placentas. FS group presented the highest catalase and GPx levels in dams, fetuses and placentas. IPC, but not FF or FS, restored normal TNF-α and IL6 expression levels in placentas whereas FS-treated animals presented the highest cytokine levels, suggesting a local inflammatory reaction. Anemia-induced high levels of HIF-1α were partially lowered by IPC and FF but further elevated by FS. Most of the negative effects associated with IDA were resolved by IPC treatment. Especially FS treatment was found to elicit hepatic damage in the dams, oxidative stress in the dams, fetuses and placenta as well as inflammation and high levels of HIF-1α in the placenta. Pregnancy outcome of FFand FS-treated animals was worse than that of IPC-treated animals.

Topics: Administration, Oral; Anemia, Iron-Deficiency; Animals; Disease Models, Animal; Female; Ferric Compounds; Ferrous Compounds; Humans; Hypoxia-Inducible Factor 1, alpha Subunit; Inflammation Mediators; Interleukin-6; Oxidative Stress; Placenta; Pregnancy; Pregnancy Outcome; Rats, Sprague-Dawley; Tumor Necrosis Factor-alpha

The adverse interactions between iron supplements and malaria have driven the assessment of new therapeutic options for anemia prophylaxis in areas holoendemic for falciparum malaria.. To determine the responses of circulating non-transferrin-bound iron (NTBI) and plasma iron to three different oral iron compounds--ferrous sulfate, sodium iron ethylenediaminetetraacetate (NaFeEDTA), and iron polymaltose (IPM)--in women with marginal iron stores.. Serum samples from 10 Guatemalan women with marginal iron stores were collected every 90 minutes over a period of 270 minutes, after the individually randomized administration of 100 mg of iron from each of the three studied iron compounds or water alone. Serum iron concentration was quantified by the ferrozine method, and circulating NTBI concentration was determined with a fluorometric competitive binding assay. Kinetic responses and maximal cumulative changes in serum concentrations of iron and NTBI were compared between the four treatments. Comparison was made with data from the same protocol in iron-adequate men.. The serum iron and NTBI responses to ferrous sulfate were significantly greater than those to water and the other two iron compounds. Serum iron responses to IPM did not differ from those to water alone.. The administration of the two "slow-release" iron compounds, NaFeEDTA and IPM, resulted in a highly significant suppression of the appearance of NTBI in the circulation in the postsupplement period. These two bioavailable forms of iron supplement could represent a safe option for supplementation in malarial areas. The slope of the iron-NTBI relationship is steeper in men than in women.

Topics: Adult; Dietary Supplements; Edetic Acid; Female; Ferric Compounds; Ferrous Compounds; Guatemala; Humans; Iron; Iron Deficiencies; Malaria, Falciparum; Middle Aged; Plasmodium falciparum; Transferrin

Haemoglobin mass in a female endurance athlete was measured via carbon monoxide rebreathing upon diagnosis of iron-deficiency anemia (haemoglobin concentration = 8.8 g/dL, ferritin = 9.9 ng/mL) and regularly during treatment thereafter. Haemoglobin mass increased by 49% in the 2 wk following an intramuscular iron injection and continued to increase with oral iron supplementation for 15 wk. The presented case illustrates that haemoglobin mass is readily responsive to iron supplementation in a severely iron-deficient anemic athlete and that changes can be tracked efficiently using the CO-rebreathing method.

Topics: Administration, Oral; Anemia, Iron-Deficiency; Biomarkers; Breath Tests; Drug Administration Schedule; Female; Ferric Compounds; Ferrous Compounds; Hematinics; Hemoglobins; Humans; Injections, Intramuscular; Physical Endurance; Running; Time Factors; Treatment Outcome; Young Adult

Iron deficiency is a common worldwide problem leading to several morbidities including anemia. Although oral iron is the first choice in iron deficiency therapy, it may produce gastrointestinal (GI) and liver disorders. The aim of our study was to evaluate: (1) acute toxicity (LD(50)) in different oral iron compounds such as ferrous sulfate (FS), iron amino chelate (AC) and iron polymaltose complex (IPC) and (2) possible differences in early and late toxicity in the GI tract and liver between them.. Hematological variables, liver enzymes, oxidative stress markers (thiobarbituric-acid-reactive substances, reduced glutathione, catalase, glutathione peroxidase, CuZn superoxide dysmutase) in intestinal mucosa and liver homogenates, and morphological parameters (gross anatomy, histology) were evaluated in non-anemic rats.. LD(50) was lower (p < 0.01) in FS versus iron AC and IPC. The liver enzymes were increased in the FS group (p < 0.05). The FS group presented gastric mucosal erosions and the iron AC group showed submucosal hemorrhages in the lower GI tract (colon and rectum) versus the IPC and control groups. In the small intestine, the villi/crypt ratio and goblet cells per villus were significantly (p < 0.01) reduced in the FS and iron AC groups versus IPC. The eosinophils per villus were increased (p < 0.01) in the FS and iron AC groups versus the IPC and control groups. Ferritin was elevated (p < 0.01) in the IPC group versus FS and iron AC in the small intestine and liver. The oxidative stress markers were all significantly (p < 0.01) altered in the FS and iron AC groups versus the IPC and control groups in the intestinal mucosa and liver.. FS exhibited important acute toxicity as well as early and late GI tract and liver toxicity. Despite showing similar LD(50) as IPC, iron AC presented differences regarding early and late GI tract and liver toxicity versus IPC.

Topics: Animals; Chemical and Drug Induced Liver Injury; Female; Ferric Compounds; Ferritins; Ferrous Compounds; Gastrointestinal Diseases; Intestinal Mucosa; Iron Chelating Agents; Lethal Dose 50; Liver Function Tests; Male; Oxidative Stress; Rats; Rats, Sprague-Dawley; Time Factors; Toxicity Tests, Acute

The vast majority of erythropoietin (EPO)-treated peritoneal dialysis (PD) patients require iron supplementation. Most authors and clinical practice guidelines recommend primary oral iron supplementation in PD patients because it is more practical and less expensive. However, numerous studies have clearly demonstrated that oral iron therapy is unable to maintain EPO-treated PD patients in positive iron balance. Once patients become iron-deficient, intravenous iron administration has been found to more effectively augment iron stores and hematologic response than does oral therapy. We recently performed a prospective, cross-over trial in 28 iron-replete PD patients and showed that twice-monthly outpatient iron polymaltose infusions (200 mg) were a practical and safe alternative to oral iron. That treatment produced significant increases in hemoglobin concentration and body iron stores. The additional expense of intravenous iron therapy was completely offset by reductions in EPO dosage. Careful monitoring of iron stores is important in patients receiving intravenous iron supplementation in view of epidemiologic links with infection and cardiovascular disease. Nevertheless, a growing body of evidence suggests that, as has been found for hemodialysis patients, intravenous iron therapy is superior to oral iron supplementation in EPO-treated PD patients.

Topics: Administration, Oral; Erythropoietin; Ferric Compounds; Ferritins; Ferrous Compounds; Hemoglobins; Humans; Infusions, Intravenous; Iron; Peritoneal Dialysis; Recombinant Proteins; Transferrin

The bioavailability or iron from iron(III)hydroxide polymaltose complex (ferric polymaltose, Fe-PM) was studied in human volunteers with normal or depleted iron stores as well as in patients with iron deficiency anemia. From an oral iron dose of 100 mg neutron activated Fe-PM, starved subjects with depleted iron stores absorbed significantly less (p < 0.003) 59Fe (3.91 +/- 2.24%, mean +/- SD) as compared to the reference, aqueous 59Fe(II) ascorbate solution (13.8 +/- 6.19%). Using non-radiolabeled, commercial Fe-PM no postabsorptive serum iron increase was found after oral Fe-PM (100 mg Fe dosage) in a group of 7 patients with haemorrhagic or posthaemorrhagic iron deficiency anemia. In addition, almost no haemoglobin increase was observed in 9 patients during a 4-weeks treatment period when given Fe-PM (100-300 mg Fe/d) on empty stomach, whereas subsequent treatment with ferrous sulfate (100-200 mg Fe/d) was therapeutically effective (0.15-0.23 g/dl Hb-increase/d). When given 100 or 300 mg Fe/d Fe-PM together with meal, 3 out of 6 patients showed a higher iron utilization rate (3.4-11.9%/d) than given without meal (0.5-7.5%/d). In vitro incubation studies demonstrated that Fe-PM is very stable at neutral pH. A small release of iron from the high molecular weight complex was found only at low pH (< 2). However, high amounts of ionic iron were measured in the reaction tubes after incubating solutions of Fe-PM together with ascorbic acid. This finding could explain the somewhat higher bioavailability of Fe-PM when given with vitamin C containing meals.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Oral; Adult; Anemia, Hypochromic; Biological Availability; Ferric Compounds; Ferrous Compounds; Hematinics; Hemorrhage; Humans; Hydrogen-Ion Concentration; Iron; Iron Radioisotopes; Neutron Activation Analysis

Pharmacokinetic measurements of ferrous sulphate and ferric hydroxide-polymaltose complex on anaemic and non-anaemic rats have shown different postabsorption serum iron levels, invasion and elimination constants and distribution volumes for the two preparations. But nevertheless the absorption and utilization ratios of iron from both preparations are equal. It is therefore not justified to calculate utilization ratios for chemically different iron preparations on the basis of postabsorption serum iron measurements. Similar pharmacokinetic differences of these two iron preparations could also be found in clinical trials, which means that different serum iron increase results in an equal utilization ratio for both preparations. It is clear that ferrous sulphate and ferric hydroxide-polymaltose complex must have a different absorption mechanism. The postulated absorption mechanism is in agreement with all the facts known today and does explain the pharmacokinetic difference between the investigated preparations.

Topics: Anemia; Animals; Ferric Compounds; Ferrous Compounds; Intestinal Absorption; Iron; Kinetics; Male; Models, Biological; Rats

In both experimental animals and human subjects iron absorption over a wide dosage range was quantitatively equivalent from ferrous salts and a ferric polymaltose complex under basal conditions. The comparable bioavailability was maintained when demand was increased by iron depletion or erythroid stimulation and depressed by expansion of body stores or impaired erythropoiesis. This common pattern for iron retention from both salt and complex supports the interchangeable use of these products in therapy of absolute iron deficiency.

Topics: Animals; Ascorbic Acid; Biological Availability; Ferric Compounds; Ferrous Compounds; Humans; In Vitro Techniques; Intestinal Absorption; Iron; Iron Deficiencies; Male; Rats

This paper reports a study of the pharmacokinetics of ferrous sulphate and ferric-hydroxide-polymaltose complex (Hw 6400, Ferrum Hausmann) administered orally and intravenously to anaemic and non-anaemic rats of both sexes. Radiolabelled ferrous sulphate and ferric-hydroxide-polymaltose complex was used to study iron utilization after oral administration. Measurements of radioactivity in serum, packed red cells, whole blood, liver, kidney, spleen, bone and in some cases in the gastrointestinal tract were made following a range of dosages between 0.84 and 41.9 mg Fe/kg. No significant difference in bioavailability or iron utilization was found between the two iron preparations. Pharmacokinetic measurements following i.v. administration showed different distribution volumes, iron clearance and elimination constants for the two preparations. This difference in pharmacokinetic behaviour following oral administration, particularly in the case of non-anaemic rats, was confirmed by the observation that a 10- to 20 fold smaller dose of FeSO4 than of iron-polymaltose complex was required to achieve the same rise in serum iron. It is therefore not justifiable to draw conclusions about the bioavailability of chemically different iron preparations (iron salts and iron hydroxide complexes) on the basis of AUC values for serum iron increases observed in non-anaemic animals or human subjects.

Topics: Administration, Oral; Anemia, Hypochromic; Animals; Female; Ferric Compounds; Ferrous Compounds; Injections, Intravenous; Intestinal Absorption; Iron; Kinetics; Male; Rats; Rats, Inbred Strains; Tissue Distribution