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ItemProtocol for a randomised, multicentre, four-arm, double-blinded, placebo-controlled trial to assess the benefits and safety of iron supplementation with malaria chemoprevention to children in Malawi: IRMA trial(BMJ PUBLISHING GROUP, 2023-10)INTRODUCTION: Approximately 40% of children aged 6-59 months worldwide are anaemic. Iron-containing multiple micronutrient powders (MNPs) and iron supplements (syrup/drops) are used to combat anaemia in children in different parts of the world. However, evidence for functional benefits of iron supplementation in children is scarce, and potential risks remain poorly defined, particularly concerning diarrhoea and malaria. This trial aims to determine if: (1) the efficacy of iron supplements or MNPs (containing iron) given with malaria chemoprevention is superior to malaria chemoprevention alone, or (2) if the efficacy of malaria chemoprevention alone is superior to placebo on child cognitive development. METHODS AND ANALYSIS: IRMA is a four-arm, parallel-group, double-blinded, placebo-controlled, triple-dummy, randomised trial in Southern Malawi. The study recruits 2168 infants aged 6 months, with an intervention period of 6 months and a post-intervention period of a further 6 months. Children are randomised into four arms: (1) No intervention (placebo); (2) malaria chemoprevention only; (3) MNPs and malaria chemoprevention; and (4) iron syrup and malaria chemoprevention. The primary outcome, cognitive development (Cognitive Composite Score (CogCS)), is measured at the end of the 6 months intervention. Secondary outcomes include CogCS at a further 6 months post-intervention, motor, language and behavioural development, physical growth and prevalence of anaemia and iron deficiency. Safety outcomes include incidence of malaria and other infections, and prevalence of malaria parasitaemia during and post-intervention period. ETHICS AND DISSEMINATION: The trial is approved by the National Health Sciences Research Committee (#19/01/2213) (Malawi) and the Human Research Ethics Committee (WEHI: 19/012) (Australia). Written informed consent in the local language is obtained from each participant before conducting any study-related procedure. Results will be shared with the local community and internationally with academic and policy stakeholders. TRIAL REGISTRATION NUMBER: ACTRN12620000386932.
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ItemNo Preview AvailableAnemia, iron deficiency, meat consumption, and hookworm infection in women of reproductive age in northwest Vietnam(AMER SOC TROP MED & HYGIENE, 2008-03)Iron deficiency anemia poses an important public health problem for women of reproductive age living in developing countries. We assessed the prevalence of iron deficiency and anemia and associated risk factors in a community-based sample of women living in a rural province of northwest Vietnam. A cross-sectional survey, comprised of written questionnaires and laboratory analysis of hemoglobin (Hb), ferritin, transferrin receptor, and stool hookworm egg count, was undertaken, and the soluble transferrin receptor/log ferritin index was calculated. Of 349 non-pregnant women, 37.53% were anemic (Hb < 12 g/dL), and 23.10% were iron deficient (ferritin < 15 ng/L). Hookworm infection was present in 78.15% of women, although heavy infection was uncommon (6.29%). Iron deficiency was more prevalent in anemic than non-anemic women (38.21% versus 14.08%, P < 0.001). Consumption of meat at least three times a week was more common in non-anemic women (51.15% versus 66.67%, P = 0.042). Mean ferritin was lower in anemic women (18.99 versus 35.66 ng/mL, P < 0.001). There was no evidence of a difference in prevalence (15.20% versus 17.23%, P = 0.629) or intensity (171.07 versus 129.93 eggs/g, P = 0.412) of hookworm infection between anemic and non-anemic women. Although intensity of hookworm infection and meat consumption were associated with indices of iron deficiency in a multiple regression model, their relationship with hemoglobin was not significant. Anemia, iron deficiency, and hookworm infection were prevalent in this population. Intake of meat was more clearly associated with hemoglobin and iron indices than hookworm. An approach to addressing iron deficiency in this population should emphasize both iron supplementation and deworming.
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ItemNo Preview AvailableUndernutrition among children in South and South-East Asia(WILEY, 2010-09)Undernutrition remains a major public health problem among children living in Asia. Although the burden is maximal among poorer, rural and Indigenous communities, the problem affects the majority in many Asian countries, especially in South Asia. In order to prevent the pervasive consequences of undernutrition, strategies that address this burden are required. Successful implementation of strategies may be limited by the complex aetiology of undernutrition, including the political setting. Rising food insecurity because of climate change, land use for biofuel production and the recent global financial crisis threaten to exacerbate childhood malnutrition. In this review, we describe the burden of undernutrition among Asian children and discuss contributing factors and potential solutions.
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ItemNo Preview AvailableVitamin B-12, folate, iron, and vitamin A concentrations in rural Indian children are associated with continued breastfeeding, complementary diet, and maternal nutrition(OXFORD UNIV PRESS, 2011-11)BACKGROUND: Determinants of vitamin B-12, folate, iron, and vitamin A concentrations in young children in rural south Asia are poorly understood. These micronutrients are crucial for the production of hemoglobin and have other important physiologic functions. OBJECTIVE: We sought to develop explanatory models for concentrations of vitamin B-12, folate, ferritin, and retinol binding protein (RBP) in children aged between 1 and 2 y in rural Karnataka, India. DESIGN: We performed a cross-sectional study in 12-23-mo-old toddlers who lived in 2 rural districts of Karnataka, India. For each child, data concerning dietary, food-security, and sociodemographic and maternal factors were obtained, and serum vitamin B-12, folate, ferritin, and RBP were measured. Multiple regression and structural equation modeling were applied to determine associations with micronutrient concentrations. RESULTS: Of 396 sampled children, 254 children (65.6%) had at least one micronutrient deficiency. With the use of multiple regression, continued breastfeeding was independently associated with the concentration of each micronutrient [(log) vitamin B-12: standardized coefficient of -0.30 (P < 0.001); folate: standardized coefficient of +0.20 (P < 0.001); (log) ferritin: standardized coefficient of -0.18 (P = 0.004); (log) RBP: standardized coefficient of-0.21 (P < 0.001)]. Children who continued to breastfeed received less nutrition from complementary foods and belonged to poorer families with higher food insecurity. A structural equation model for children's vitamin B-12 concentrations was developed that highlighted the interrelation between wealth, continued breastfeeding, complementary diet, and vitamin B-12 concentrations in children. CONCLUSIONS: Micronutrient deficiencies are common in this population. Rural Indian children between 1 and 2 y of age who continue to breastfeed should be especially targeted during micronutrient-supplementation programs. This trial was registered in the Australian and New Zealand Clinical Trials Registry as ACTRN12611000596909.
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ItemNo Preview AvailableEffects of Daily Iron Supplementation in 2- to 5-Year-Old Children: Systematic Review and Meta-analysis(American Academy of Pediatrics, 2013-04-01)BACKGROUND AND OBJECTIVES: Iron deficiency (ID) is the most common cause of anemia worldwide. The prevalence is highest among preschool-aged children. Iron is widely administered to children with or at risk for ID, but evidence of benefit among 2- to 5-year-old children has not been evaluated by systematic review. We summarize the evidence for the benefit and safety of daily iron supplementation with regard to hematologic, growth, and cognitive parameters in 2 to 5 year olds. METHODS: Electronic databases, regional databases, thesis repositories, gray literature, and references of studies and previous reviews were searched. We included randomized controlled trials that compared daily oral iron supplementation with control in 2 to 5 year olds. A random-effects meta-analysis was used to synthesize predefined outcomes reported by at least 2 studies. RESULTS: Of 9169 references, 15 studies met the inclusion criteria, none of which were at low risk of bias. Children receiving iron supplementation had a mean end point hemoglobin of 6.97 g/L (P < .00001; I(2) = 82%) greater than controls, whereas mean end point ferritin was 11.64 µg/L (P < .0001; I(2) = 48%) greater. No trials reported the effects of iron supplementation on ID or iron deficiency anemia, and only one reported on anemia. Limited evidence suggested that iron supplementation produced a small improvement in cognitive development but had no effect on physical growth. CONCLUSIONS: In 2 to 5 year olds, daily iron supplementation increases hemoglobin and ferritin. There is a concerning lack of data on the effect of iron supplementation on clinically important outcomes including anemia, ID anemia, ID, and cognitive development. Additional interventional studies in this age group are needed.
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ItemEffects of daily iron supplementation in primary-school-aged children: systematic review and meta-analysis of randomized controlled trials(CMA-CANADIAN MEDICAL ASSOC, 2013-11-19)BACKGROUND: Anemia is an important public health and clinical problem. Observational studies have linked iron deficiency and anemia in children with many poor outcomes, including impaired cognitive development; however, iron supplementation, a widely used preventive and therapeutic strategy, is associated with adverse effects. Primary-school-aged children are at a critical stage in intellectual development, and optimization of their cognitive performance could have long-lasting individual and population benefits. In this study, we summarize the evidence for the benefits and safety of daily iron supplementation in primary-school-aged children. METHODS: We searched electronic databases (including MEDLINE and Embase) and other sources (July 2013) for randomized and quasi-randomized controlled trials involving daily iron supplementation in children aged 5-12 years. We combined the data using random effects meta-analysis. RESULTS: We identified 16 501 studies; of these, we evaluated 76 full-text papers and included 32 studies including 7089 children. Of the included studies, 31 were conducted in low- or middle-income settings. Iron supplementation improved global cognitive scores (standardized mean difference 0.50, 95% confidence interval [CI] 0.11 to 0.90, p = 0.01), intelligence quotient among anemic children (mean difference 4.55, 95% CI 0.16 to 8.94, p = 0.04) and measures of attention and concentration. Iron supplementation also improved age-adjusted height among all children and age-adjusted weight among anemic children. Iron supplementation reduced the risk of anemia by 50% and the risk of iron deficiency by 79%. Adherence in the trial settings was generally high. Safety data were limited. INTERPRETATION: Our analysis suggests that iron supplementation safely improves hematologic and nonhematologic outcomes among primary-school-aged children in low- or middle-income settings and is well-tolerated.
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ItemNo Preview AvailableAgreement Between Venous and Capillary Haemoglobin Concentrations in Bangladeshi Children (P10-105-19).(Elsevier BV, 2019-06)Objectives: There are concerns that capillary haemoglobin (Hb) concentrations do not agree with venous Hb, which has implications for global estimates of anaemia largely derived from capillary Hb. In children enrolled in the Benefits and Risks of Iron Supplementation in Children (BRISC) trial, we examined differences between Hb concentrations collected from venous and capillary blood samples, and predictors of these differences. Methods: Hb concentrations were measured in 3300 children at 8 months of age. Capillary Hb concentrations were measured during screening of children for inclusion in the trial. Venous Hb was measured up to 10 days after screening, during enrolment. All Hb measurements used the HemoCue® 301. In children who received both capillary and venous measurements, Hb means, standard deviations, and anaemia prevalence statistics were derived. Paired t-tests were used to compare means across groups. Pearson's correlation coefficients and a Bland-Altman plot were used to examine agreement between capillary and venous Hb. A kappa coefficient was used to examine agreement in diagnosis of anaemia between the two methods. Lastly, differences in mean venous and capillary Hb concentrations between phlebotomists were calculated using ANOVA. Results: All 3300 children will have completed baseline Hb measurements by February 2019. The current abstract presents preliminary data up to December 2018 for 2485 children. Venous and capillary Hb concentrations were moderately correlated (r = 0.62). Prevalence of anaemia using venous samples was 44.8% and using capillary samples was 69.5%. Accounting for chance, the % agreement (kappa coefficient) between the methods for diagnosis of anaemia was 34.8%. Mean Hb concentrations were significantly higher in venous than capillary samples (mean ± SD: 11.0 ± 1.0 vs 10.4 ± 1.0 g/dL, P < 0.001). This is confirmed in the Bland-Altman plot. No differences in Hb were observed between phlebotomists. Conclusions: Significant differences exist in the diagnosis of anaemia using capillary vs venous samples. Capillary Hb measurements should not be used as a surrogate for venous Hb as they may incorrectly estimate the prevalence of anaemia. Results indicated that global estimates of anaemia based on capillary Hb may be misrepresenting true estimates. Funding Sources: NHMRC.
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ItemImmediate impact of stay-at-home orders to control COVID-19 transmission on socioeconomic conditions, food insecurity, mental health, and intimate partner violence in Bangladeshi women and their families: an interrupted time series(ELSEVIER SCI LTD, 2020-11)BACKGROUND: Stay-at-home orders (lockdowns) have been deployed globally to control COVID-19 transmission, and might impair economic conditions and mental health, and exacerbate risk of food insecurity and intimate partner violence. The effect of lockdowns in low-income and middle-income countries must be understood to ensure safe deployment of these interventions in less affluent settings. We aimed to determine the immediate impact of COVID-19 lockdown orders on women and their families in rural Bangladesh. METHODS: An interrupted time series was used to compare data collected from families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown. We also assessed women's experiences of intimate partner violence during the pandemic. RESULTS: Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent. 2414 (99·9%, 95% CI 99·6-99·9) of 2417 mothers were aware of, and adhering to, the stay-at-home advice. 2321 (96·0%, 95·2-96·7) of 2417 mothers reported a reduction in paid work for the family. Median monthly family income fell from US$212 at baseline to $59 during lockdown, and the proportion of families earning less than $1·90 per day rose from five (0·2%, 0·0-0·5) of 2422 to 992 (47·3%, 45·2-49·5) of 2096 (p<0·0001 comparing baseline with lockdown period). Before the pandemic, 136 (5·6%, 4·7-6·6) of 2420 and 65 (2·7%, 2·1-3·4) of 2420 families experienced moderate and severe food insecurity, respectively. This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001). Mothers' depression and anxiety symptoms increased during the lockdown. Among women experiencing emotional or moderate physical violence, over half reported it had increased since the lockdown. INTERPRETATION: COVID-19 lockdowns present significant economic, psychosocial, and physical risks to the wellbeing of women and their families across economic strata in rural Bangladesh. Beyond supporting only the most socioeconomically deprived, support is needed for all affected families. FUNDING: National Health and Medical Research Council, Australia.