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Whole-blood donors are at increased risk for iron deficiency and anaemia. The current standard of haemoglobin monitoring is insufficient to ensure the maintenance of proper iron reserves and donor health. We aimed to determine the effects of ferritin-guided donation intervals for blood donor health and blood supply in the Netherlands. In this stepped-wedge cluster-randomised trial (FIND'EM), the 138 fixed and mobile donation centres in the Netherlands are organised into 29 geographical clusters and the clusters were randomly assigned to four treatment groups, with two groups being further split into two per a protocol amendment. Eligible donors were whole-blood donors who consented for use of their leftover material in the study. Each group was sequentially crossed over from the existing policy (haemoglobin-based screening; control) to a ferritin-guided donation interval policy over a 3-year period. In the intervention groups, in addition to the existing haemoglobin screening, ferritin was measured in all new donors and at every fifth donation in repeat donors. Subsequent donation intervals were extended to 6 months if ferritin concentrations were 15–30 ng/mL and to 12 months if they were less than 15 ng/mL. Outcomes were measured cross-sectionally across all donation centres at four timepoints. Primary outcomes were ferritin and haemoglobin concentrations, iron deficiency, and haemoglobin-based deferrals. We assessed all outcomes by sex and menopausal status and significance for primary outcomes was indicated by a p value of less than 0·0125. This trial is registered in the Dutch trial registry, NTR6738, and is complete. Between Sept 11, 2017, and Nov 27, 2020, 412 888 whole-blood donors visited a donation centre, and we did measurements on samples from 37 621 donations from 36 099 donors. Over 38 months, ferritin-guided donation intervals increased mean ferritin concentrations (by 0·18 log10 ng/mL [95% CI 0·15–0·22; p<0·0001] in male donors, 0·10 log10 ng/mL [0·06–0·15; p<0·0001] in premenopausal female donors, and 0·17 log10 ng/mL [0·12–0·21; p<0·0001] in postmenopausal female donors) and mean haemoglobin concentrations (by 0·30 g/dL [95% CI 0·22–0·38; p<0·0001] in male donors, 0·12 g/dL [0·03–0·20; p<0·0074] in premenopausal female donors, and 0·16 g/dL [0·05–0·27; p<0·0044] in postmenopausal female donors). Iron deficiency decreased by 36–38 months (odds ratio [OR] 0·24 [95% CI 0·18–0·31; p<0·0001] for male donors, 0·49 [0·37–0·64; p<0·0001] for premenopausal female donors, and 0·24 [0·15–0·37; p<0·0001] for postmenopausal female donors). At 36–38 months, haemoglobin-based deferral decreased significantly in male donors (OR at 36–38 months 0·21 [95% CI 0·10–0·40, p<0·0001]) but not significantly in premenopausal or postmenopausal female donors (0·81 [0·54–1·20; p=0·29] and 0·50 [95% CI 0·25–0·98; p=0·051], respectively). Ferritin-guided donation intervals significantly improved haemoglobin and ferritin concentrations and significantly decreased iron deficiency over the study period. Haemoglobin-based deferrals decreased significantly for male donors, but not female donors. Although this intervention is overall beneficial for maintenance of iron and haemoglobin concentrations in donors, increased efforts are needed to recruit and retain donors. The Sanquin Research Programming Committee.

Limits on the frequency of whole blood donation exist primarily to safeguard donor health. However, there is substantial variation across blood services in the maximum frequency of donations allowed. We compared standard practice in the UK with shorter inter-donation intervals used in other countries. In this parallel group, pragmatic, randomised trial, we recruited whole blood donors aged 18 years or older from 25 centres across England, UK. By use of a computer-based algorithm, men were randomly assigned (1:1:1) to 12-week (standard) versus 10-week versus 8-week inter-donation intervals, and women were randomly assigned (1:1:1) to 16-week (standard) versus 14-week versus 12-week intervals. Participants were not masked to their allocated intervention group. The primary outcome was the number of donations over 2 years. Secondary outcomes related to safety were quality of life, symptoms potentially related to donation, physical activity, cognitive function, haemoglobin and ferritin concentrations, and deferrals because of low haemoglobin. This trial is registered with ISRCTN, number ISRCTN24760606, and is ongoing but no longer recruiting participants. 45 263 whole blood donors (22 466 men, 22 797 women) were recruited between June 11, 2012, and June 15, 2014. Data were analysed for 45 042 (99·5%) participants. Men were randomly assigned to the 12-week (n=7452) versus 10-week (n=7449) versus 8-week (n=7456) groups; and women to the 16-week (n=7550) versus 14-week (n=7567) versus 12-week (n=7568) groups. In men, compared with the 12-week group, the mean amount of blood collected per donor over 2 years increased by 1·69 units (95% CI 1·59–1·80; approximately 795 mL) in the 8-week group and by 0·79 units (0·69–0·88; approximately 370 mL) in the 10-week group (p<0·0001 for both). In women, compared with the 16-week group, it increased by 0·84 units (95% CI 0·76–0·91; approximately 395 mL) in the 12-week group and by 0·46 units (0·39–0·53; approximately 215 mL) in the 14-week group (p<0·0001 for both). No significant differences were observed in quality of life, physical activity, or cognitive function across randomised groups. However, more frequent donation resulted in more donation-related symptoms (eg, tiredness, breathlessness, feeling faint, dizziness, and restless legs, especially among men [for all listed symptoms]), lower mean haemoglobin and ferritin concentrations, and more deferrals for low haemoglobin (p<0·0001 for each) than those observed in the standard frequency groups. Over 2 years, more frequent donation than is standard practice in the UK collected substantially more blood without having a major effect on donors' quality of life, physical activity, or cognitive function, but resulted in more donation-related symptoms, deferrals, and iron deficiency. NHS Blood and Transplant, National Institute for Health Research, UK Medical Research Council, and British Heart Foundation.

Objective To investigate the effects of delayed umbilical cord clamping, compared with early clamping, on infant iron status at 4 months of age in a European setting.Design Randomised controlled trial.Setting Swedish county hospital.Participants 400 full term infants born after a low risk pregnancy.Intervention Infants were randomised to delayed umbilical cord clamping (≥180 seconds after delivery) or early clamping (≤10 seconds after delivery).Main outcome measures Haemoglobin and iron status at 4 months of age with the power estimate based on serum ferritin levels. Secondary outcomes included neonatal anaemia, early respiratory symptoms, polycythaemia, and need for phototherapy.Results At 4 months of age, infants showed no significant differences in haemoglobin concentration between the groups, but infants subjected to delayed cord clamping had 45% (95% confidence interval 23% to 71%) higher mean ferritin concentration (117 μg/L v 81 μg/L, P<0.001) and a lower prevalence of iron deficiency (1 (0.6%) v 10 (5.7%), P=0.01, relative risk reduction 0.90; number needed to treat=20 (17 to 67)). As for secondary outcomes, the delayed cord clamping group had lower prevalence of neonatal anaemia at 2 days of age (2 (1.2%) v 10 (6.3%), P=0.02, relative risk reduction 0.80, number needed to treat 20 (15 to 111)). There were no significant differences between groups in postnatal respiratory symptoms, polycythaemia, or hyperbilirubinaemia requiring phototherapy.Conclusions Delayed cord clamping, compared with early clamping, resulted in improved iron status and reduced prevalence of iron deficiency at 4 months of age, and reduced prevalence of neonatal anaemia, without demonstrable adverse effects. As iron deficiency in infants even without anaemia has been associated with impaired development, delayed cord clamping seems to benefit full term infants even in regions with a relatively low prevalence of iron deficiency anaemia.Trial registration Clinical Trials NCT01245296.

Background In-home iron fortification for infants in developing countries is recommended for control of anaemia, but low absorption typically results in >80% of the iron passing into the colon. Iron is essential for growth and virulence of many pathogenic enterobacteria. We determined the effect of high and low dose in-home iron fortification on the infant gut microbiome and intestinal inflammation. Methods We performed two double-blind randomised controlled trials in 6-month-old Kenyan infants (n=115) consuming home-fortified maize porridge daily for 4 months. In the first, infants received a micronutrient powder (MNP) containing 2.5 mg iron as NaFeEDTA or the MNP without iron. In the second, they received a different MNP containing 12.5 mg iron as ferrous fumarate or the MNP without the iron. The primary outcome was gut microbiome composition analysed by 16S pyrosequencing and targeted real-time PCR (qPCR). Secondary outcomes included faecal calprotectin (marker of intestinal inflammation) and incidence of diarrhoea. We analysed the trials separately and combined. Results At baseline, 63% of the total microbial 16S rRNA could be assigned to Bifidobacteriaceae but there were high prevalences of pathogens, including Salmonella Clostridium difficile, Clostridium perfringens, and pathogenic Escherichia coli. Using pyrosequencing, +FeMNPs increased enterobacteria, particularly Escherichia/Shigella (p=0.048), the enterobacteria/bifidobacteria ratio (p=0.020), and Clostridium (p=0.030). Most of these effects were confirmed using qPCR; for example, +FeMNPs increased pathogenic E. coli strains (p=0.029). +FeMNPs also increased faecal calprotectin (p=0.002). During the trial, 27.3% of infants in +12.5 mgFeMNP required treatment for diarrhoea versus 8.3% in −12.5 mgFeMNP (p=0.092). There were no study-related serious adverse events in either group. Conclusions In this setting, provision of iron-containing MNPs to weaning infants adversely affects the gut microbiome, increasing pathogen abundance and causing intestinal inflammation. Trial registration number NCT01111864.

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.

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.

Adolescent girls are an important target group for micronutrient interventions particularly in Sub-Saharan Africa where adolescent pregnancy and micronutrient deficiencies are common. When consumed in sufficient amounts and at levels appropriate for the population, fortified foods may be a useful strategy for this group, but little is known about their effectiveness and timing (regarding menarche), particularly in resource-poor environments. We evaluated the effect of consuming multiple micronutrient-fortified biscuits (MMB), sold in the Ghanaian market, 5 d/week for 26 weeks compared with unfortified biscuits (UB) on the micronutrient status of female adolescents. We also explored to what extent the intervention effect varied before or after menarche. Ten2Twenty-Ghana was a 26-week double-blind, randomised controlled trial among adolescent girls aged 10–17 years (n 621) in the Mion District, Ghana. Biomarkers of micronutrient status included concentrations of Hb, plasma ferritin (PF), soluble transferrin receptor (TfR) and retinol-binding protein (RBP), including body-iron stores. Intention-to-treat analysis was supplemented by protocol-specific analysis. We found no effect of the intervention on PF, TfR and RBP. MMB consumption did not affect anaemia and micronutrient deficiencies at the population level. MMB consumption increased the prevalence of vitamin A deficiency by 6·2 % (95 % CI (0·7, 11·6)) among pre-menarche girls when adjusted for baseline micronutrient status, age and height-for-age Z-score, but it decreased the prevalence of deficient/low vitamin A status by −9·6 % (95 % CI (−18·9, −0·3)) among post-menarche girls. Consuming MMB available in the market did not increase iron status in our study, but reduced the prevalence of deficient/low vitamin A status in post-menarcheal girls.

Background Iron-deficiency anemia (IDA) remains a significant public health concern, particularly among women of reproductive age in developing countries. Despite ongoing supplementation and fortification programs, the prevalence of anemia remains high due to challenges such as poor compliance, logistical constraints, and limited access to iron and dietary sources. Cooking in iron cookware has been proposed as a low-cost, culturally acceptable strategy for improving dietary iron intake; however, evidence of its effectiveness remains mixed. This randomized controlled trial (RCT) aimed to evaluate the effectiveness of consuming food cooked in iron pots, coupled with a structured behaviour change programme, on improving hemoglobin and ferritin levels among non-pregnant, non-lactating women of reproductive age in rural India. Methods A community-based randomized controlled trial will be conducted in selected rural blocks of Akola and Wardha districts in Maharashtra, India. Eligible women (aged 18–45 years, non-pregnant, non-lactating) will be randomized into two groups: an intervention group receiving iron cookware along with structured behaviour change communication sessions, and a control group receiving non-iron cookware. Iron status indicators (hemoglobin, ferritin, serum iron, transferrin saturation, and total iron-binding capacity) will be assessed at baseline, 6 months, and 12 months after the intervention. Patient compliance with iron pot usage will be monitored through food diaries, spot checks, and interviews. Barriers and facilitators of adherence will be explored through qualitative assessments. Discussion It is anticipated that women using iron cookware with structured counselling support will demonstrate significant improvements in anemia and iron deficiency indicators compared to controls. This study will also identify the practical, cultural, and economic barriers affecting patient compliance with cooking in iron pots. The findings will contribute to the evidence base for promoting iron cookware as a sustainable intervention in rural population settings. The results will inform community health strategies and align with India’s Anemia Mukt Bharat initiative. Trial registration This randomized controlled trial was prospectively registered with the Clinical Trials Registry–India (CTRI) under the registration number CTRI/2025/04/085829, dated April 28, 2025.

Background Iron deficiency anemia (IDA) is one of the most common problems during pregnancy. The aim of this research was to determine the effect of educational program based on Theory of Planned Behavior (TPB) on promoting nutritional behaviors preventing anemia in a pregnant woman in Shiraz city, Iran. Methods This quasi-experimental study was done on 150 pregnant women (75 experimental and 75 control groups) who were selected using randomly sampling method in in Shiraz city, Iran, in 2020–2021. The educational intervention for the experimental group included six educational sessions for 50 or 55 min-based TPB model. A questionnaire consisted of items about demographic information, TPB constructs (attitude, perceived behavioral control, subjective norms and behavioral intention) was used to measure the nutritional behaviours preventing iron deficiency anemia in pregnancy women before and 3 months after the intervention. Results The results showed that before the educational intervention, there was no significant difference between the two groups in terms of knowledge, attitude, perceived behavioral control, subjective norms, behavioral intention and nutritional performance; however, three months after the educational intervention, the experimental group showed a significant increase in each of the mentioned variables. For example the mean and standard deviation score of behavioral intention after intervention in the experimental group was significantly increased (25.57 ± 1.66, P  = 0.001),and the mean and standard deviation score of performance after intervention in the experimental group was significantly increased (31.03 ± 2.19, P = 0.001), ( P  < 0.05). Conclusions After the educational intervention, the experimental group showed a significant increase in of the knowledge, attitude, perceived behavioral control, subjective norms, behavioral intention and nutritional performance. Therefore the results of the study showed positive effect of nutrition educational intervention program base on TPB model on improvement of iron deficiency anemia preventive behaviours in the pregnancy women.

Background More than half of women in India are anemic. Anemia can result in fatigue, poor work productivity, higher risk of pre-term delivery, and maternal mortality. The Indian government has promoted the use of iron-folic acid supplements (IFA) for the prevention and treatment of anemia for the past five decades, but uptake remains low and anemia prevalence high. Current programs target individual-level barriers among pregnant women and adolescents, but a more comprehensive approach that targets multiple levels among all women of reproductive age is needed to increase uptake of IFA and iron-rich foods. Methods The Reduction in Anemia through Normative Innovations (RANI) project is a norms-based intervention to reduce anemia among women of reproductive age. We will evaluate the intervention through a clustered randomized controlled trial in Odisha, India. We will collect data at three time points (baseline, midline, and end line). For the study, we selected 89 clusters of villages, which we randomized into treatment and control on a 1:1 basis. The treatment arm will receive the RANI project components while the control arm will receive usual care. Fifteen clusters (40–41 villages) were selected and 4000 women (2000 in each arm) living in the selected clusters will be randomly selected to take part in data collection. Women in both study arms will have their hemoglobin concentrations measured. They will also complete in-person surveys about their knowledge, attitudes, perceptions of iron folic acid supplements, and nutritional intake. We will also select a smaller cohort of 300 non-pregnant women (150 in each arm) from this cohort for additional physical activity and cognitive testing. We will conduct both within- and between-group comparisons (treatment and control) at baseline, midline and end line using t-tests. We will also conduct structural equation modeling to examine how much each factor accounts for IFA use and hemoglobin levels. Discussion This RCT will enable us to examine whether a social norms-based intervention can increase uptake of iron folic acid supplements and iron rich foods to reduce anemia. Trial registration This trial was registered with Clinical Trial Registry- India (CTRI) ( CTRI/2018/10/016186 ) on 29 October 2018.