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ObjectiveIron-containing micronutrient powders (MNPs) reduce anaemia in African infants, but the current high iron dose (12.5 mg/day) may decrease gut Bifidobacteriaceae and Lactobacillaceae, and increase enteropathogens, diarrhoea and respiratory tract infections (RTIs). We evaluated the efficacy and safety of a new MNP formula with prebiotic galacto-oligosaccharides (GOS) combined with a low dose (5 mg/day) of highly bioavailable iron.DesignIn a 4-month, controlled, double-blind trial, we randomised Kenyan infants aged 6.5–9.5 months (n=155) to receive daily (1) a MNP without iron (control); (2) the identical MNP but with 5 mg iron (2.5 mg as sodium iron ethylenediaminetetraacetate and 2.5 mg as ferrous fumarate) (Fe group); or (3) the identical MNP as the Fe group but with 7.5 g GOS (FeGOS group).ResultsAnaemia decreased by ≈50% in the Fe and FeGOS groups (p<0.001). Compared with the control or FeGOS group, in the Fe group there were (1) lower abundances of Bifidobacterium and Lactobacillus and higher abundances of Clostridiales (p<0.01); (2) higher abundances of virulence and toxin genes (VTGs) of pathogens (p<0.01); (3) higher plasma intestinal fatty acid-binding protein (a biomarker of enterocyte damage) (p<0.05); and (4) a higher incidence of treated RTIs (p<0.05). In contrast, there were no significant differences in these variables comparing the control and FeGOS groups, with the exception that the abundance of VTGs of all pathogens was significantly lower in the FeGOS group compared with the control and Fe groups (p<0.01).ConclusionA MNP containing a low dose of highly bioavailable iron reduces anaemia, and the addition of GOS mitigates most of the adverse effects of iron on the gut microbiome and morbidity in African infants.Trial registration numberNCT02118402.

Although iron is commonly used to correct iron deficiency anemia (IDA) in chronic kidney disease (CKD), its effect on kidney function is unclear. To assess this, we randomly assigned patients with stage 3 and 4 CKD and IDA to either open-label oral ferrous sulfate (69 patients to 325 mg three times daily for 8 weeks) or intravenous iron sucrose (67 patients to 200 mg every 2 weeks, total 1 g). The primary outcome was the between-group difference in slope of measured glomerular filtration rate (mGFR) change over two years. The trial was terminated early on the recommendation of an independent data and safety monitoring board based on little chance of finding differences in mGFR slopes, but a higher risk of serious adverse events in the intravenous iron treatment group. mGFR declined similarly over two years in both treatment groups (oral -3.6 ml/min per 1.73 m2, intravenous -4.0 ml/min per 1.73 m2, between-group difference -0.35 ml/min per 1.73 m2; 95% confidence interval -2.9 to 2.3). There were 36 serious cardiovascular events among 19 participants assigned to the oral iron treatment group and 55 events among 17 participants of the intravenous iron group (adjusted incidence rate ratio 2.51 (1.56–4.04)). Infections resulting in hospitalizations had a significant adjusted incidence rate ratio of 2.12 (1.24–3.64). Thus, among non-dialyzed patients with CKD and IDA, intravenous iron therapy is associated with an increased risk of serious adverse events, including those from cardiovascular causes and infectious diseases.

Anemia is a common complication of inflammatory bowel diseases (IBD) This multicenter study tested the noninferiority and safety of a new intravenous iron preparation, ferric carboxymaltose (FeCarb), in comparison with oral ferrous sulfate (FeSulf) in reducing iron deficiency anemia (IDA) in IBD. Two hundred patients were randomized in a 2:1 ratio (137 FeCarb:63 FeSulf) to receive FeCarb (maximum 1,000 mg iron per infusion) at 1-wk intervals until the patients' calculated total iron deficit was reached or FeSulf (100 mg b.i.d.) for 12 wk. The primary end point was change in hemoglobin (Hb) from baseline to week 12. The median Hb improved from 8.7 to 12.3 g/dL in the FeCarb group and from 9.1 to 12.1 g/dL in the FeSulf group, demonstrating noninferiority (P= 0.6967). Response (defined as Hb increase of >2.0 g/dL) was higher for FeCarb at week 2 (P= 0.0051) and week 4 (P= 0.0346). Median ferritin increased from 5.0 to 323.5 mug/L at week 2, followed by a continuous decrease in the FeCarb group (43.5 mug/L at week 12). In the FeSulf group, a moderate increase from 6.5 to 28.5 mug/L at week 12 was observed. Treatment-related adverse events (AEs) occurred in 28.5% of the FeCarb and 22.2% of the FeSulf groups, with discontinuation of study medication due to AEs in 1.5% and 7.9%, respectively. FeCarb is effective and safe in IBD-associated anemia. It is noninferior to FeSulf in terms of Hb change over 12 wk, and provides a fast Hb increase and a sufficient refill of iron stores.

Oral iron preparations are used as first-line treatment for iron deficiency anemia (IDA), but their gastrointestinal side effects prevent patients from appropriate adherence. We recently conducted a randomized, double-blind, phase 3 non-inferiority study to evaluate the efficacy and safety of two dosages of ferric citrate hydrate (FC) compared with sodium ferrous citrate (SF) in patients with IDA. FC at both 500 and 1000 mg/day was non-inferior to SF at 100 mg/day in terms of the change in the hemoglobin concentration at Week 7 from baseline. Logistic regression analysis suggested that the cumulative proportion of patients who achieved the target hemoglobin concentration (≥ 13.0 g/dL in male patients and ≥ 12.0 g/dL in female patients) at Week 7 was highest among those treated with FC at 1000 mg/day, followed by SF at 100 mg/day and FC at 500 mg/day. Both dosages of FC were well tolerated in patients with IDA. The incidences of nausea and vomiting were significantly lower in the FC treatment groups than in the SF group. In conclusion, FC has potential to be an oral iron preparation with sufficient efficacy for the treatment of IDA and a lower risk of nausea and vomiting.

Background About 2–3 % of the population participates in blood donation programmes. Each whole blood donation or ten apheresis donations cause a loss of 200–250 mg of iron. As a result, one of the most common risks of regular blood donors is iron deficiency. Although this has been known for decades, in most countries, iron status is currently not assessed or treated in this population. Premenopausal women are particularly affected, as they have lower iron reserves and higher daily requirements. Besides anaemia, iron deficiency may lead to fatigue and impaired cognitive and physical performance. Current iron preparations for intravenous administration are well tolerated and allow for application of large doses up to 1 g in one visit. Our hypothesis is that in blood donors with iron deficiency, intravenously administered iron is more efficient and as safe as oral iron supplementation. Since anaemia is one of the most frequent reasons for permanent or intermittent donor deferral, maintaining an iron-replete donor pool may help to prevent shortages in blood supply and to avoid iron deficiency-related comorbidities. Methods/design In this randomised clinical trial we include male and female blood donors aged ≥18 and ≤65 years with a ferritin value of ≤30 ng/ml. Stratified by gender, participants are randomized with a web-based randomisation tool in a 1:1 ratio to either 1 g of intravenously administered ferric carboxymaltose or 10 g of iron fumarate supplements at one to two daily doses of 100 mg each. Eight to 12 weeks after the first visit, iron status, blood count and symptoms are assessed in both groups. The primary endpoint is the difference in transferrin saturation (%) following the intervention between both groups. Secondary endpoints include other parameters of iron metabolism and red blood cell count, the number of patients with drug-related adverse events, and subjective symptoms including those of the restless legs syndrome, quality of life, and fatigue. Discussion Iron supplementation administered intravenously in non-anaemic but iron-deficient blood donors could represent an effective strategy to protect blood donors from comorbidities related with iron deficiency and therefore improve blood donor wellbeing. Furthermore, iron supplementation will help to maintain an iron-replete blood donor pool. Trial registration EudraCT: 2013-000327-14, Clinical Trials Identifier: NCT01787526 . Registered on 6 February 2013.

In patients with heart failure with reduced ejection fraction and iron deficiency, ferric carboxymaltose therapy did not appear to differ from placebo in the composite of death, heart-failure hospitalizations, or walk distance.

Cancer-related anemia is common and multifactorial in origin. Functional iron deficiency (FID) is now recognized as a cause of iron-restricted erythropoiesis and may be one of the major reasons for lack of response to treatment with Erythropoietic Stimulating Agents (ESAs). Numerous studies have shown that intravenous (IV), but not oral, iron therapy effectively provides sufficient iron for optimal erythropoiesis in anemic patients with chronic renal disease receiving ESA therapy. The use of IV iron has also been suggested in the cancer setting. Six recent studies have tested this assumption and are summarized in this review. Four formulations of IV iron are available in Europe, with different pharmacokinetics, iron bioavailability, and risk of acute adverse drug reactions. Conclusion: Limited iron stores and FID are common causes of response failure during ESA treatment in cancer patients and should be diagnosed. There is now substantial scientific support for the use of IV iron supplementation to improve response and this has been acknowledged in international and national guidelines. Prospective long-term data on the safety of IV iron in this setting are still awaited. Recommendations concerning the optimal formulation, doses, and schedule of iron supplementation to ESA treatment in cancer-related anemia are provisional awaiting data from prospective, randomized trials.

Ferric carboxymaltose (FCM) is widely used to correct anemia and replenish iron stores rapidly, particularly in Western populations. However, lower doses of FCM are typically used in East Asia, with limited research on their effectiveness, especially in postpartum women. This randomized controlled trial aimed to assess the efficacy of low-dose FCM compared with oral ferrous sulfate in increasing postpartum hemoglobin (Hb) levels and replenishing iron stores in East Asian women. Sixty postpartum women with Hb levels < 10 g/dL and serum ferritin ≤ 30 ng/mL were randomized to receive either intravenous FCM (500 mg at baseline and 2 weeks) or oral ferrous sulfate (210 mg daily for 4 weeks). The primary outcome was the increase in Hb levels at 2 weeks post-enrollment. Secondary outcomes included serum ferritin, transferrin saturation, the Edinburgh Postnatal Depression Scale (EPDS) score, and adverse events at 4 weeks. The FCM group demonstrated a significantly greater increase in Hb levels at 2 weeks (mean difference 0.42 g/dL; 95% CI: 0.12–0.72; P =  0.006), with markedly higher ferritin (adjusted mean difference 356.0 ng/mL; 95% CI: 321.0–403.0; P <  0.001) and transferrin saturation (adjusted mean difference 10.76%; 95% CI: 4.20–17.31; P =  0.002) at 4 weeks. Although there was no significant difference in final Hb levels at 4 weeks (mean difference 0.36 g/dL; 95% CI: -0.01–0.72; P =  0.055), the FCM group had a lower median EPDS score (median difference -3.0; 95% CI: -5.0 to -1.0; P =  0.002) and fewer gastrointestinal side effects, including constipation and nausea. Hypophosphatemia occurred asymptomatically in three patients in the FCM group. These findings suggest that low-dose FCM infusion is highly effective in increasing Hb levels at 2 weeks post-enrollment, with fewer gastrointestinal side effects and higher ferritin levels observed at 4 weeks post-enrollment compared with oral ferrous sulfate. This study was registered at the UMIN Clinical Trials Registry, which meets the requirements of the ICMJE, on December 1, 2021 (ID: UMIN000046049).

In patients with heart failure and iron deficiency, intravenous iron therapy improved functional capacity and the quality of life. The benefit was similar in patients with anemia and those without anemia. Iron therapy may have a role in treating heart failure when iron deficiency is also present. In patients with heart failure and iron deficiency, intravenous iron therapy improved functional capacity and the quality of life. Iron therapy may have a role in treating heart failure when iron deficiency is also present. Recent developments in the management of chronic heart failure in patients with an impaired left ventricular ejection fraction have changed the natural history of this clinical syndrome and improved patients' outcomes. 1 , 2 However, the normal daily activities of many patients with heart failure remain restricted; they report symptoms of fatigue and dyspnea that adversely affect their quality of life, leading to high morbidity. 3 , 4 Therapeutic options to improve functional capacity in patients with heart failure are limited, and novel therapies are needed. Numerous mechanisms unrelated to hemodynamic dysfunction may underlie impaired exercise tolerance in patients with chronic heart failure. Among . . .

Background Iron supplements can cause discoloration in children’s teeth, which can impact their confidence and social interactions. This staining may discourage parents from continuing treatment. The study compared different types of iron supplements—encapsulated (liposomal, sucrosomial) and non-encapsulated (ferrous sulfate, iron polysaccharide complex)—to assess their impact on tooth discoloration. Materials and methods In this in vitro study, a total of 65 intact anterior primary teeth were examined. Their initial color was assessed using an X-RITE spectrophotometer in the CIELab system. The control group was treated with normal saline, while experimental groups were exposed to iron supplements: Liposofer, Amivital Ferrous Sulphate, SiderAl, and Feramax. The teeth were immersed in these solutions for two weeks before final color measurements. SPSS software version 27 was used for statistical analysis, including paired t-tests, one-way ANOVA, LSD multiple comparison tests, Tamhane’s T2 test, and the Shapiro-Wilk test. The level of statistical significance was set at P  < 0.05. Results The mean ∆E parameter (color assessment) of primary teeth was significantly higher in the groups treated with Amivital Ferrous Sulphate and SiderAl iron supplements compared to the other groups ( P  < 0.05). Among the iron supplements, Liposofer and Feramax showed the lowest mean ∆E parameter for primary teeth ( P  < 0.05). Conclusion The type of iron supplement may play a key role in primary tooth discoloration. These findings suggest that polysaccharide and liposomal iron supplements may cause less discoloration in vitro, though further clinical research is needed to confirm these findings.