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Anemia in pediatrics is often associated with chronic conditions such as chronic kidney disease (CKD). It can worsen the disease prognosis and affect quality of life. Injectable dosage forms are predominantly used in its treatment with various side effects. This randomized and parallel clinical trial aimed to compare the effectiveness of oral lactoferrin with intravenous (IV) iron dextran in managing anemia resulted from CKD in pediatrics. The study involved 60 children diagnosed with CKD-related anemia who were allocated into two separate groups. Group 1 consisted of 30 pediatric patients who received 100 mg of oral lactoferrin daily for a period of 3 months. Group 2 included 30 pediatric patients who were given IV iron dextran at a dosage of 50 mg three times weekly for 3 months. Both treatments are effective in treating CKD-induced anemia in pediatrics; however, oral lactoferrin demonstrated superior efficacy as there was a significant change within that group in levels of Hb, RBCs, MCH, iron, RDW-SD, MCHC, IL-6, and GDF-15 before and after treatment. In contrast, IV iron dextran showed significant changes within its group in iron, GFR, IL-6, GDF-15, and RDW-SD. After 3 months of treatment, no significant differences were observed between the two groups.

Background Feeding milk substitutes with low iron content or whole milk without iron supplementation is considered a major factor in developing iron-deficiency anemia in neonatal dairy calves. Young calves are often supplemented with iron dextran injections on the first day of life to prevent anemia. However, the effects of preventive treatment and the presence of disease on serum iron (Fe) concentrations, serum ferritin levels, and hematological blood parameters during the early neonatal stages have not been examined in detail. Therefore, we examined and evaluated the effects of iron dextran injections and health status on the development of hematocrit (Ht), red blood cells (RBC), hemoglobin concentration (Hb), erythrocyte indices (mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration), Fe, and serum ferritin concentrations in dairy calves within the first 10 days of life. The suitability of serum ferritin as a reliable indicator of anemia in very young calves was evaluated by correlating ferritin concentrations with known laboratory diagnostic parameters of anemia. Results Iron supplementation significantly increased Fe levels ( P  = 0.048) but did not affect serum ferritin levels in neonatal calves. Fe concentrations were significantly lower in diseased than healthy calves ( P  = 0.0417). Iron supplementation significantly affected the health status, as observed in Ht (P treat =0.0057; P health =0.0097), RBC (P treat =0.0342; P health =0.0243), and Hb (P treat =0.0170; P health =0.0168). Serum ferritin levels did not significantly correlate with Fe levels. Both groups showed marked differences in ferritin levels, with the highest levels measured on day 2. Fe concentrations showed weak negative correlations with Hb and Ht levels on day 3 (ρ=-0.45; P  = 0.0034 and ρ=-0.045; P  = 0.0032, respectively). RBC count showed strong positive correlations with Hb and Ht levels (ρ = 0.91 and ρ = 0.93; P  < 0.001). Conclusion Iron dextran injections increased Fe concentrations but reduced Ht level, RBC count, and Hb level. The presence of diseases led to a reduction in Fe and higher values of Ht, RBC, and Hb in moderate disease than in severe disease. Due to physiological fluctuations during the first 3 days of life, serum ferritin level seems unuseful for evaluating iron storage before day 4 of life.

Iron deficiency anemia (IDA) is commonly treated with iron formulations. Despite the expanding acceptance of iron polymaltose complex (IPC) among clinicians, there is sparse and contradictory evidence regarding its efficacy in the management of IDA in children. This systematic review and meta-analysis aimed to assess the effectiveness of IPC in the treatment and prevention of IDA in children. We searched the Cochrane Central Register of Controlled Trials, MEDLINE and Epistemonikos for all randomized control trials (RCTs) comparing oral IPC with standard oral iron supplementation for the treatment or prevention of IDA in children. We independently screened the titles and abstracts of identified trials before the full text of relevant trials was evaluated for eligibility. We then independently extracted data on the methods, interventions, outcomes, and risk of bias from the included trials. A random-effects model was used to estimate the risk ratios and mean differences with 95% confidence intervals. Eight trials comprising 493 randomized patients were included and analyzed using three comparison groups. The comparison group of which was used to evaluate IPC and ferrous sulphate (FS) for treatment of IDA showed that IPC is less effective in increasing Hb (MD -0.81, 95% CI -1.08 to -0.53; I = 48%,  < 0.001; six studies, 368 participants; high certainty of evidence), ferritin (MD -21.24, 95% CI -39.26 to -3.23, random-effects; I = 65%,  = 0.020; 3 studies, 183 participants; moderate certainty of evidence) and MCV levels (MD -3.20, 95% CI -5.35 to -1.05;  = 0.003; one study, 103 participants; low certainty of evidence). There was no difference in the occurrence of side effects between IPC and FS group (MD 0.78, 95% CI 0.47 to 1.31; I = 4%,  = 0.35; three studies, 274 participants; high certainty of evidence). There was moderate to high certainty evidence that FS is superior to IPC with a clinically meaningful difference in improving the Hb and ferritin levels in the treatment of IDA in children. There was no difference in the occurrence of gastrointestinal side effects with high certainty evidence between the IPC and FS groups. The body of evidence did not allow a clear conclusion regarding the effectiveness of IPC with iron gluconate and iron bisglycinate in the prevention and treatment of IDA. The certainty of evidence was low. Adequately powered and high-quality trials with large sample sizes that assess both hematological and clinical outcomes are required.

Background Intravenous (IV) iron is frequently used to treat iron deficiency/anemia in patients who are unable to tolerate oral iron or the oral iron is not sufficient toreplete iron requirements. However, safety concerns regarding the potential increase in oxidative stress and other adverse effects persist and it remains unclear whether all iron preparations are equivalent. Indeed, the comparative risk of adverse events with IV iron preparations has not been extensively assessed. We hypothesize that IV iron leads to changes in oxidative stress, endothelial function, and potential renal damage depending on the iron formulation (related to the generation of “free” or catalytic labile iron) and this may result in more tubular and glomerular injury manifested as increased proteinuria and raised neutrophil gelatinase–associated lipocalin (NGAL) levels in patients with chronic kidney disease (CKD). Methods IRON-CKD is a prospective, open-label, explorative, randomized, single-center study designed to compare the safety and efficacy of three parenteral iron preparations: low-molecular-weight iron dextran–Cosmofer, iron sucrose–Venofer, and iron isomaltoside–Monofer. The study includes 40 adults who have established CKD stages 3–5 and serum ferritin (SF) of less than 200 μg/L or transferrin saturation (TS) of less than 20% (or both); they were randomly assigned in a 1:1:1:1 ratio to 200 mg iron dextran, 200 mg iron sucrose, 200 mg iron isomaltoside, or 1000 mg iron isomaltoside. After randomization, participants undergo baseline assessments and then an iron infusion. Each participant is followed up at 2 h, day 1, week 1, and months 1 and 3. At each follow-up visit, patients undergo clinical review, measurement of pulse wave velocity (PWV), blood tests for renal function, and collection of serum/plasma samples for oxidative stress and inflammatory markers. The primary outcomes are measures of oxidative stress, inflammatory markers, and markers of acute renal injury in comparison with baseline measures of each iron preparation and between each of the iron preparations. Secondary objectives include effects on hematinic profiles and hemoglobin concentrations, changes in arterial stiffness, incidence of significant side effects, and change in patients’ quality of life. Results Between October 2015 and April 2018, 521 individuals were identified as potential participants; 216 were contacted, 56 expressed an interest, 49 attended a screening visit, and 40 were confirmed to meet the eligibility criteria and were randomly assigned. The mean age was 58.3 (standard error of the mean 4.4) years, and 23 (58%) were male. All patients were white and English-speaking. The mean SF was 66.6 μg/L, TS was 21.2%, and hemoglobin was 121.6 g/L at randomization for the whole group. The mean estimated glomerular filtration rate was 27.8 mL/min, the urinary protein/creatinine ratio was 104.3 mg/mmol, and CRP was 6.65 mg/L. Discussion IRON-CKD will provide important information on the short-term effects of three preparations of IV iron in CKD patients with biochemical functional or absolute iron deficiency on measures of oxidative stress, inflammation, endothelial function, and renal injury. Trial registration European Clinical Trials Database (EudraCT) number 2010-020452-64 .

Dinitrosyl iron complexes (DNICs) are the most abundant nitric oxide (NO) metabolites in NO-producing cells and can be used as a platform for photochemical vehicles for NO donors. However, not much is known about the photochemical dynamics of DNICs. This study investigates the photoexcitation dynamics of a mononuclear DNIC ligated with 2-mercaptoethanol, [(HOCH2CH2S)2Fe(NO)2]−, in D2O solution through femtosecond infrared spectroscopy. Approximately 70% of the excited [(HOCH2CH2S)2Fe(NO)2]− at 400 nm relaxes back to the ground state with a time constant of 270 ps, and the remaining dissociates NO− with a time constant of 630 ps. The resulting mononitrosyl iron complex, [(HOCH2CH2S)2Fe(NO)(D2O)2], formed by a rapid coordination of D2O molecule to the nascent photoproduct, [(HOCH2CH2S)2Fe(NO)], reacts with the abundant thiolate, HOCH2CH2S−, in solution, producing [(HOCH2CH2S)3Fe(NO)]− with a rate constant of 1.3 × 107 M−1s−1. The detailed photochemical dynamics described herein lays the groundwork for the development of NO− donors using DNICs with controlled and tunable photoreactivity for potential therapeutic applications.

Deferasirox (DEFR), when administered BID, improves iron overload and decreases DEFR-related adverse effects in patients with β-thalassemia major. However, the pharmacokinetic (PK) disposition of DEFR and the iron–DEFR complex (Fe-[DEFR]2) in this dosing strategy is unclear. Chromatographic analysis was performed using a solvent delivery system coupled to an HPLC-UV detector to determine the steady-state concentrations of DEFR (CDEFR) and Fe-(DEFR)2 (CFe-[DEFR]2) in β-thalassemia major patients (n = 8) following either once-daily or BID dosing, during which the PK parameters of the 2 dosing schedules were compared. An HPLC-UV system for the analysis of blood samples following solid-phase extraction was validated. Patients who received 40 mg/kg of DEFR had higher mean CDEFR and CFe-[DEFR]2 values at all sampling times. However, concentrations of iron-DEFR complex were similar in patients who received 30 or 40 mg/kg of DEFR in the once-daily group at the 6- to 24-hour sampling times. There was no significant difference in any of the PK parameters; however, DEFR administration BID increased the mean trough levels of DEFR (183.8 [157.5] μmol/L) compared with once daily (87.7 [56.8] μmol/L), whereas all the patients had increased peak levels per individual DEFR dose when they were switched from once daily to BID (139.0 [59.8] μmol/L vs 289.2 [145.8] μmol/L, respectively). Splitting the dose increased the peak levels of DEFR per unit dose in all patients and tends to increase drug exposures, but there were no significant differences in DEFR PK parameter estimates. Switching from once daily to BID may be considered for patients with an inadequate response to chelation therapy to achieve optimal drug levels. Further research is needed with a larger sample size to determine the clinical importance of the significant results due to the interindividual variability of DEFR.

IntroductionErythropoietin (EPO) is a commonly used option in the treatment of chemotherapy-induced anaemia (CIA). However, ∼30–50% of patients fail to achieve an adequate response after initial treatment. Prior studies have demonstrated that intravenous iron might synergistically improve therapeutic response to EPO treatment in this patient population.Methods and analysisWe will perform this multicentre, randomised, open-label, parallel-group, active controlled non-inferiority study to compare the two combination therapies of EPO plus intravenous iron regimen versus doubling the dose of EPO in patients with CIA who have an inadequate response to initial EPO treatment at a routine dose. A total of 603 patients with an increase in haemoglobin (Hb) <1 g/dL will be enrolled and randomised to one of the three study treatment groups at a 1:1:1 ratio Group 1: EPO treatment at the original dose plus intravenous iron dextran 200 mg every 3 weeks (Q3W) for 15 weeks; Group 2: EPO treatment at the original dose plus intravenous iron dextran 100 mg, twice a week for 5 weeks; Group 3: the control group, doubling the EPO dose without preplanned iron supplementation. The primary outcome measure to compare is the Hb response rate at week 15 and the secondary end points involve therapeutic blood transfusions. Time-to-progression, adverse events and quality of life will also be evaluated.Ethics and disseminationAll participants will provide informed consent; the study protocol has been approved by the independent ethics committee of Shanghai East Hospital. This study would clearly demonstrate the potential benefit of combining epoetin treatment with intravenous iron supplementation. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of CIA in China.Trial registration numberNCT02731378.

Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran. Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores. Until recently, the only available form of intravenous iron was iron dextran, which is associated with significant adverse reactions, including anaphylaxis and death. Sodium ferric gluconate complex (SFGC) was recently approved for use in the U.S. under FDA's priority drug review. This Phase IV study was designed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control. This multicenter, crossover, randomized, double blind, placebo-controlled prospective comparative study was performed in hemodialysis patients requiring at least 125mg of elemental iron. The historical control was obtained from a meta-analysis of four publications examining outcomes in patients exposed to iron dextran. SFGC naïve patients were administered SFGC without a test dose, undiluted, at a rate of 125mg over 10 minutes, and compared to placebo comprising bacteriostatic saline. A total of 2534 patients were enrolled. The incidence of drug intolerance (an adverse event precluding re-exposure) was significantly less [0.44%, confidence interval (CI) 0.21 to 0.71%] after SFGC as compared to the iron dextran control (2.47%, CI 1.87 to 3.07%, P < 0.0001), but higher than after placebo (0.1%, P = 0.02). There was no difference found between SFGC and placebo in serious adverse events. A single life-threatening event occurred after SFGC (0.04%, CI 0.00 to 0.22%), which was significantly less than following iron dextran (0.61%, CI 0.36 to 0.86%), P = 0.0001. SFGC is well tolerated when given by intravenous push without a test dose. SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran. The routine use of iron dextran in hemodialysis patients should be discontinued.

Three iron complexes were synthesized through green and sustainable procedures via chelation with salicylic acid, 3-methyl-1-phenyl-pyrazol-5-one, and ethylacetoactate under solvent-free conditions at room temperature. The synthesis assured the concept of both the twelve principles of Green Chemistry and Sustainability Commands. 48 male Wistar albino rats were administered gentamicin (GM) at a dose of 80 mg kg-1 day-1, with or without (I-SA), (I-MPP), (I-EAA) (120 mg kg-1 day-1) to evaluate the complexes' potential protective effects against GM-induced hepatotoxicity and nephrotoxicity. Oxidative stress markers and DNA fragmentation increased significantly, while the activity of the antioxidant enzymes SOD and CAT notably decreased. The study findings suggest that the three complexes serve as novel natural antioxidants, mitigating oxygen free radicals, lipid peroxidation, and DNA damage in gentamicin-treated rats. These compounds hold promise as potential natural drugs in future applications.

An open‐chain iron pyridine‐NHC framework is expanded utilizing a benzimidazole moiety to deepen the understanding of the impact of electronic variations on iron NHC epoxidation catalysts, especially regarding the stability. The thereby newly obtained iron(II) NHC complex is characterized and employed in olefin epoxidation. It is remarkably temperature tolerant and achieves a TOF of ca. 10 000 h−1 and TON of ca. 700 at 60 °C in the presence of the Lewis acid Sc(OTf)3, displaying equal stability, but lower activity than the unmodified iron pyridine‐NHC (pre‐)catalyst. In addition, a synthetic approach towards another ligand containing 2‐imidazoline units is described but formylation as well as hydrolysis hamper its successful synthesis. An open‐chain iron pyridine‐NHC framework is expanded utilizing a benzimidazole moiety. The new iron(II) NHC complex is characterized and employed in olefin epoxidation. It is remarkably temperature tolerant and achieves a TOF of ca. 10 000 h−1 and TON of ca. 700 at 60 °C with Sc(OTf)3 as additive.