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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.

BackgroundIntravenous iron therapy with ferric derisomaltose (FDI) has been shown to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, its effects across different age groups remain unclear. This analysis of the Effectiveness of Intravenous Iron Treatment versus Standard Care in Patients with Heart Failure and Iron Deficiency (IRONMAN) trial explored the efficacy and safety of FDI across age groups.MethodsThe IRONMAN trial was a prospective, open-label, blinded end point randomised controlled trial enrolling patients with HFrEF and iron deficiency. This prespecified analysis stratified the population into four quarters by age group: <67 years, 67–73 years, 74–79 years, >79 years. The primary outcome was a composite of recurrent heart failure hospitalisations and cardiovascular death. Secondary outcomes included changes in haemoglobin and quality of life. Clinical outcomes comparing FDI versus usual care in each age subgroup were analysed by the method of Lin et al for recurrent events and Cox proportional hazards model for time to first event. Interactions between age and treatment effects were explored.ResultsAmong 1137 randomised patients (median age 73 years), the primary outcome rate ratio (FDI vs usual care) was 0.87 (95% CI 0.61 to 1.23) in patients <67 years, 0.93 (95% CI 0.66 to 1.32) in those aged 67–73 years, 0.88 (95% CI 0.59 to 1.33) in those aged 74–79 years and 0.66 (95% CI 0.45 to 0.96) in those aged >79 years (p-interaction=0.38). Improvements in haemoglobin and quality of life scores at 4 months did not differ statistically across age groups (p-interaction=0.92 and 0.64, respectively). Older patients were more symptomatic at baseline, with higher N-terminal-pro B-type natriuretic peptide levels and poorer renal function, but safety outcomes did not differ across age groups.ConclusionsWe found no evidence that the effects of FDI on heart failure hospitalisations, cardiovascular death, haemoglobin and quality of life differed by age. These findings support its use in patients with HFrEF and iron deficiency, including older adults.Trial registration number NCT02642562.

Background Antenatal multiple micronutrient supplementation (MMS) has been shown to be more effective than iron-folic acid (IFA) alone in reducing adverse pregnancy and birth outcomes. However, there is a concern that MMS containing 30 mg of iron may be less effective in reducing maternal anemia compared to IFA supplements containing 60 mg of iron. This poses a clinical and programmatic dilemma for countries with a high burden of maternal anemia (> 40% prevalence) where the World Health Organization (WHO) recommends using IFA with 60 mg of iron. Methods/design We will conduct an individually randomized, quadruple-blind superiority trial of daily antenatal MMS in Dar es Salaam, Tanzania ( n  = 6381 pregnant women). Participants will be randomized to receive a daily MMS regimen during pregnancy containing 60 mg iron, 45 mg iron, or 30 mg iron at a ratio of 1:1:1. The trial participants, outcome assessors (research staff and care providers), investigators, trial statistician, and data analysts will be blinded. Pregnant women will be enrolled in the trial before 20 weeks of gestation and will receive the randomized MMS regimen from enrollment until the time of pregnancy outcome/delivery. The primary outcome is maternal third-trimester moderate or severe anemia (Hb < 10.0 g/dL). The proportion of women who have moderate or severe anemia at 32 weeks of gestation will be compared between MMS containing 60 mg iron versus MMS containing 30 mg iron, as well as MMS containing 45 mg iron versus MMS containing 30 mg iron. Secondary outcomes include maternal hemoglobin concentration, anemia, maternal iron deficiency, and maternal iron deficiency anemia at 32 weeks gestation and 6 weeks postpartum; preeclampsia, antepartum bleeding, postpartum hemorrhage, maternal peripartum infection, pregnancy-related death, symptoms consistent with depression, fatigue, and maternal malaria during pregnancy and 42 days following; fetal death, stillbirth, birth weight, low birthweight, gestational age at birth, preterm birth, birthweight for gestational age, and small-for-gestational age birth; infant hemoglobin concentrations, infant iron status, neonatal death, and infant death at 6 weeks of age; and maternal side effects. Relative risks for binomial outcomes and mean differences for continuous outcomes and their 95% confidence intervals will be calculated for all the primary and secondary outcomes. Discussion This study will produce causal evidence on whether MMS containing 60 or 45 mg of iron is superior to MMS containing 30 mg of iron in reducing maternal anemia and improving other important maternal and infant health outcomes. The findings of this study will inform Tanzania and similar contexts on the optimal formulation of MMS as many countries begin transitioning from IFA to MMS. Trial registration ClinicalTrials.gov NCT06079918. Registered on 2023–10-06. Trial status The trial is recruiting. We report protocol version 1.7 dated March 2, 2025. Recruitment started with the first patient enrolled on March 3, 2025. At the submission of this manuscript on April 10, 2025, 111 participants have been randomized. Recruitment is ongoing and should be completed by December 2026.

AimWe investigated the potential of reticulocyte haemoglobin equivalent (RET-He) as an early marker of responsiveness to iron supplementation.MethodsData were obtained from a randomised controlled trial of daily iron supplementation in 356 Cambodian women (18–45 y) who received 60 mg elemental iron for 12 weeks. A fasted venous blood specimen was collected at baseline, 1-week and 12-week timepoints. Whole blood haemoglobin (g/L) and RET-He (pg) were measured using a Sysmex haematology analyser. RET-He measures were evaluated for their predictive ability on haemoglobin response to iron supplementation (defined as ≥10 g/L at 12 weeks). Receiver operating characteristic (ROC) curves were used to assess discrimination performance, and the area under the ROC curve (AUCROC) served as a measure of the ability of each predictor to discriminate between women likely or unlikely to elicit a haemoglobin response.ResultsPredictive ability (AUCROC (95% CI)) of baseline, 1-week, and change from baseline to 1-week RET-He on haemoglobin response was 0.70 (0.63 to 0.76), 0.48 (0.41 to 0.56) and 0.81 (0.75 to 0.87), respectively. Based on the Youden index, an absolute increase in RET-He of ~1.1 pg or a percentage increase of ~4.4% over 1 week were optimal thresholds to predict responsiveness to iron supplementation.ConclusionSingle timepoint RET-He measures have poor predictive ability; however, change in RET-He after 1 week was a strong predictor of haemoglobin response among Cambodian women receiving 60 mg elemental iron and can be measured easily and quickly after only 1 week of iron therapy.

To determine the prevalence, risk factors and prognosis of anemia in representative community-based patients with type 2 diabetes. Data from the Fremantle Diabetes Study Phase II (FDS2; n=1551, mean age 65.7years, 51.9% males) and Busselton Diabetes Study (BDS; n=186, mean age 70.2years, 50.0% males) cohorts, and from 186 matched BDS participants without diabetes, were analyzed. The prevalence of anemia (hemoglobin ≤130g/L males, ≤120g/L females) was determined in each sample. In FDS2, associates of anemia were assessed using multiple logistic regression and Cox proportional hazards modeling identified predictors of death during 4.3±1.2years post-recruitment. The prevalence of anemia at baseline was 11.5% in FDS2 participants, 17.8% in BDS type 2 patients and 5.4% in BDS participants without diabetes. In FDS2, 163 of 178 patients with anemia (91.6%) had at least one other risk factor (serum vitamin B12<140pmol/L, serum ferritin <30μg/L and/or transferrin saturation<20%, serum testosterone <10nmol/L (males), glitazone therapy, estimated glomerular filtration rate (eGFR) <60mL/min 1.73m2, malignancy, hemoglobinopathy). More anemic than non-anemic FDS2 patients died (28.7% versus 8.0%; P<0.001). After adjustment for other independent predictors (age as time-scale, male sex, Aboriginality, marital status, smoking, eGFR), anemia was associated with a 57% increase in mortality (P=0.015). Type 2 diabetes at least doubles the risk of anemia but other mostly modifiable risk factors are usually present. Anemia is associated with an increased risk of death after adjustment for other predictors.

Background Approximately 20% to 30% of patients awaiting cardiac surgery are anemic. Anemia increases the likelihood of requiring a red cell transfusion and is associated with increased complications, intensive care, and hospital stay following surgery. Iron deficiency is the commonest cause of anemia and preoperative intravenous (IV) iron therapy thus may improve anemia and therefore patient outcome following cardiac surgery. We have initiated the intravenous iron for treatment of anemia before cardiac surgery (ITACS) Trial to test the hypothesis that in patients with anemia awaiting elective cardiac surgery, IV iron will reduce complications, and facilitate recovery after surgery. Methods ITACS is a 1,000 patient, international randomized trial in patients with anemia undergoing elective cardiac surgery. The patients, health care providers, data collectors, and statistician are blinded to whether patients receive IV iron 1,000 mg, or placebo, at 1-26 weeks before their planned date of surgery. The primary endpoint is the number of days alive and at home up to 90 days after surgery. Results To date, ITACS has enrolled 615 patients in 30 hospitals in 9 countries. Patient mean (SD) age is 66 (12) years, 63% are male, with a mean (SD) hemoglobin at baseline of 118 (12) g/L; 40% have evidence (ferritin <100 ng/mL and/or transferrin saturation <25%) suggestive of iron deficiency. Most (59%) patients have undergone coronary artery surgery with or without valve surgery. Conclusions The ITACS Trial will be the largest study yet conducted to ascertain the benefits and risks of IV iron administration in anemic patients awaiting cardiac surgery.

Background Numerous studies have been conducted to manage anemia in surgical patients through iron supplementation as an alternative to blood transfusion. However, patients with locally advanced rectal cancer have often been excluded from these studies, due to their standard treatment involving neoadjuvant chemoradiotherapy. This study aims to evaluate the impact of intravenous versus oral iron supplementation on iron deficiency anemia in patients with rectal cancer receiving preoperative chemoradiotherapy. Methods This open-label, single-center, parallel, superiority, randomized trial includes patients with primary rectal cancer who are candidates for preoperative chemoradiotherapy and have confirmed iron-deficiency anemia. A total of 94 patients will be randomly assigned in a 1:1 ratio to receive either intravenous or oral iron supplementation. Stratification factors include age (> 70 vs. ≤ 70 years) and baseline serum hemoglobin levels (7–10 g/dL vs. 10–13 g/dL). The primary endpoint is the percentage of patients achieving normalized hemoglobin levels from the start of treatment to the day of admission for surgery. Secondary endpoints include changes in serum hemoglobin from baseline to postoperatively, changes in iron assay parameters, time needed to hemoglobin normalization, volume of blood transfusions required, and incidence of postoperative complications. Discussion This study is the first randomized controlled trial investigating the effect of iron supplementation in iron-deficient patients with rectal cancer undergoing neoadjuvant chemoradiotherapy. This trial is expected to provide evidence for the benefits of administering iron supplementation in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy. Trial registration Clinical Research Information Service (CRIS) of Republic of Korea, KCT0009260, Registered on March 21, 2024.

Evaluating early iron supplementation in non-anemic mothers with postpartum depression (PPD). This randomized, double-blind, placebo-controlled trial evaluated 70 mothers with PPD. One week after delivery, the mothers were randomly allocated in the iron-treated (50 mg elemental iron/daily) and placebo-treated groups. After 6 weeks, the improvement of PPD symptoms was compared between the groups. Ferritin significantly increased in the iron-treated group (p < 0.001), but not in the placebo group (p = 0.09). After intervention, ferritin was higher in the iron-treated group (medians: 78.2 vs. 37 mg/dl, p = 0.01). The rate of iron deficiency significantly decreased in the iron-treated group (p = 0.009), but not in the placebo group (p = 0.4). After intervention, the rate of iron deficiency was higher in the placebo group (31.4 vs. 8.5 %, p = 0.01). The Edinburgh Postnatal Depression Scale (EPDS) score significantly decreased in the iron-treated group (p < 0.001), but not in the placebo group (p = 0.13). After intervention, the EPDS score was lower in the iron-treated group (medians 9 vs. 12, p = 0.01). The improvement rate for PPD was significantly higher in the iron-treated group (42.8 vs. 20 %, p = 0.03). After intervention, mothers with continued PPD had lower ferritin than the improved mothers (41.8 vs. 67 mg/dl, p = 0.03). Mothers with continued depression had higher rate of iron deficiency compared to the improved mothers (27.1 vs. 4.5 %, p = 0.02). Early iron supplementation in mothers with PPD significantly improves the iron stores and causes a significant improvement in PPD with a 42.8 % improvement rate during 6 weeks. Continued PPD might be related to the lower postpartum ferritin levels in untreated mothers.

In India, national databases indicate anaemia prevalence of 80 % among 6-35-month-old children and 58 % among 36-59-month-old children. The present study aimed to characterise anaemia and the associated factors among infants and pre-schoolers living in rural India. Multivariate logistic regression analysis of data collected prior to an intervention trial. Fe-deficiency with anaemia (IDA), Fe deficiency with no anaemia (IDNA) and anaemia without Fe deficiency were defined. Serum ferritin, soluble transferrin receptor (sTfR) and sTfR/log ferritin index were used to indicate Fe status. Twenty-six villages of Nalgonda district, Telangana, India. Data were collected in community sites. Participants Four hundred and seventy-six infants (aged 6-12 months), 316 pre-schoolers (aged 29-56 months) and their mothers. Prevalence of anaemia among infants and pre-schoolers was 66·4 and 47·8 %, prevalence of IDA was 52·2 and 42·1 %, prevalence of IDNA was 22·2 and 29·8 %, prevalence of anaemia without Fe deficiency was 14·2 and 5·7 %. Among infants, anaemia was positively associated with maternal anaemia (OR=3·31; 95 % CI 2·10, 5·23; P<0·001), and sTfR/log ferritin index (OR=2·21; 95 % CI 1·39, 3·54; P=0·001). Among pre-schoolers, anaemia was positively associated with maternal anaemia (OR=3·77; 95 % CI 1·94, 7·30; P<0·001), sTfR/log ferritin index (OR=5·29; 95 % CI 2·67, 10·50; P<0·001), high C-reactive protein (OR=4·39; 95 % CI 1·91, 10·06, P<0·001) and young age (29-35 months: OR=1·92; 05 % CI 1·18, 3·13, P=0·009). Anaemia prevalence continues to be high among infants and pre-schoolers in rural India. Based on sTfR/ferritin index, Fe deficiency is a major factor associated with anaemia. Anaemia is also associated with inflammation among pre-schoolers and with maternal anaemia among infants and pre-schoolers, illustrating the importance of understanding the aetiology of anaemia in designing effective control strategies.

Objective. The purpose was to evaluate the treatment effect of iron proteinsuccinylate oral solution combined with vitamin A and D drops on children with nutritional iron deficiency anemia. Methods. 124 children treated in the outpatient department of our hospital from January 2017 to January 2020 were selected as the study subjects. They were randomly divided into control and observation two groups. The control group was treated with iron proteinsuccinylate oral solution (1.5 mL/kg) in the morning and evening, respectively. The observation group received adjuvant treatment with oral vitamin A and D drops based on the treatment of the control group. The treatment effect of proteinsuccinylate oral solution combined with vitamin A and D drops was evaluated by the serum iron (SI), serum ferritin (SF), and transferrin (TRF) levels, the values of CD3+, CD4+, and CD4+/CD8+, and other evaluation indicators. Results. After treatment, the SI and SF levels of children in both groups significantly increased (P<0.01) while the TRF level significantly decreased (P<0.01), and the SI and SF levels in the observation group increased more significantly, and the TRF level decreased more significantly compared with those in the control group (P<0.01). After treatment, the values of CD3+, CD4+, and CD4+/CD8+ of children in both groups significantly increased compared with those before treatment (P<0.01), and the values of CD3+, CD4+, and CD4+/CD8+ increased more significantly in the observation group compared with those in the control group (P<0.01). In addition, the evaluation results of treatment effect showed that the markedly effective rate in the observation group was significantly higher than that in the control group (P<0.01). Conclusion. Iron proteinsuccinylate oral solution combined with vitamin A and D drops can better improve the anemia symptoms in children, with high application value.