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Is untargeted iron supplementation harmful when iron deficiency is not the major cause of anaemia? Study protocol for a double-blind, randomised controlled trial among non-pregnant Cambodian women.

ABSTRACT: INTRODUCTION:The WHO recommends daily oral iron supplementation for 12 weeks in women and adolescents where anaemia prevalence is greater than 40%. However, if iron deficiency is not a major cause of anaemia, then, at best, untargeted iron supplementation is a waste of resources; at worst, it could cause harm. Further, different forms of iron with varying bioavailability may present greater risks of harm. METHODS AND ANALYSIS:A 12-week three-arm, double-blind, randomised controlled supplementation trial was conducted in Cambodia to determine if there is potential harm associated with untargeted iron supplementation. We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60?mg elemental iron as ferrous sulfate (the standard, commonly used form), 18?mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo. We will measure ferritin concentrations (to evaluate non-inferiority between the two forms of iron), as well as markers of potential harm in blood and stool (faecal calprotectin, gut pathogen abundance and DNA damage) at baseline and 12 weeks. Mixed-effects generalised linear models will be used to assess the effect of iron on ferritin concentration and markers of potential harm at 12 weeks. ETHICS AND DISSEMINATION:Ethical approval was obtained from the University of British Columbia Clinical Research Ethics Board (H18-02610), the Children's and Women's Health Centre of British Columbia Research Ethics Board (H18-02610) and the National Ethics Committee for Health Research in Cambodia (273-NECHR). Findings will be published in peer-reviewed journals, presented to stakeholders and policymakers globally and shared within participants' communities. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Registry (NCT04017598).

SUBMITTER: Fischer JA

PROVIDER: S-EPMC7430471 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Is untargeted iron supplementation harmful when iron deficiency is not the major cause of anaemia? Study protocol for a double-blind, randomised controlled trial among non-pregnant Cambodian women.

Fischer Jordie Aj JA Pei Lulu X LX Goldfarb David M DM Albert Arianne A Elango Rajavel R Kroeun Hou H Karakochuk Crystal D CD

BMJ open 20200816 8

<h4>Introduction</h4>The WHO recommends daily oral iron supplementation for 12 weeks in women and adolescents where anaemia prevalence is greater than 40%. However, if iron deficiency is not a major cause of anaemia, then, at best, untargeted iron supplementation is a waste of resources; at worst, it could cause harm. Further, different forms of iron with varying bioavailability may present greater risks of harm.<h4>Methods and analysis</h4>A 12-week three-arm, double-blind, randomised controlle ...[more]

PMID: 32801202

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Project description:Anaemia in pregnancy is a major health problem and an important cause of adverse foetomaternal outcomes in developing countries. Iron deficiency is the cause of the overwhelming majority of the cases of anaemia in pregnancy. Iron deficiency anaemia (IDA) has been linked with adverse foetal and maternal outcomes. This study investigated the prevalence of IDA and evaluated its effects on foetomaternal outcomes among parturients in Lagos, Nigeria. This was a cross-sectional study that enrolled 220 women aged 15-49 years with singleton gestation at term, between May 1, 2016, and March 31, 2017. Participants were selected by systematic sampling and baseline data were collected through interviews. Venous blood samples were obtained to measure haemoglobin and serum ferritin concentrations, and the associations between IDA (defined as anaemia and iron deficiency) and pregnancy outcomes were examined. A P-value <0.05 was considered as statistically significant. The prevalence of IDA was 12.3%. Routine antenatal iron supplementation (adjusted odds ratio 0.18, 95% confidence interval 0.07-0.46; P = 0.001) and interpregnancy interval of at least 2 years (adjusted odds ratio 0.20, 95% confidence interval 0.05-0.97; P = 0.021) have significant association with IDA. Iron deficiency anaemia was not significantly associated with adverse perinatal outcomes but there were significant associations with increased risk of blood transfusion (P = 0.001) and maternal infectious morbidities such as puerperal pyrexia (P = 0.041) and wound infection (P = 0.020). IDA is still a fairly common condition among parturients in Lagos and it's mostly associated with maternal peripartum morbidities. Adequate pregnancy spacing through the use of effective contraception and routine antenatal iron supplementations in pregnancy is a recommended preventive measure against IDA and its adverse sequelae. Future studies should adopt the use of transferrin saturation (TSAT) in compliment with serum ferritin assay as a more sensitive marker of iron deficiency.

Project description:BackgroundLittle evidence about the effects of antenatal iron supplementation on infant anaemia is available. The aim was to compare effects on six-month-old infants' Haemoglobin (Hb) concentration and anaemia of daily iron-folic acid (IFA), twice-weekly IFA with or without other micronutrients (MMN) and usual antenatal care in rural Vietnam.Methods and findingsSecondary data analysis from: a prospective population-based observational study (OS) which examined effects of antenatal psychosocial factors, anaemia and iron deficiency on infant development and health; and a three-arm cluster randomised trial (CRT) of different antenatal iron supplementation regimens. In the OS 497 women (<20 weeks gestation) from 50 randomly-selected communes participated, and in the CRT 1,258 pregnant women (<16 weeks gestation) in 104 communes were allocated randomly to trial arms. The main outcome was six-month-old infant Hb concentration. Baseline data included women's socio-demographic characteristics, reproductive health, Hb and serum ferritin. Mean differences in infant Hb and odds ratios of infant anaemia between CRT arms and OS were calculated by multivariable regression models, controlling for baseline differences and clustering, using robust standard errors. Infant anaemia prevalence was 68.6% in the OS, 47.2% daily IFA, 53.5% weekly IFA, and 50.3% MMN conditions. After adjustment, mean infant haemoglobin levels in daily IFA (mean difference = 0.95 g/dL; 95%CI 0.7-11.18); weekly IFA (0.91; 95%CI 0.69-1.12) and MMN (1.04; 95%CI 0.8-1.27) were higher than in the OS. After adjustment there were lower odds ratios of anaemia among infants in the daily IFA (OR = 0.31; 95% CI 0.22-0.43), weekly IFA (0.38; 95%CI 0.26-0.54) and MMN (0.33; 95%CI 0.23-0.48) groups than in the OS.ConclusionsInfant anaemia is a public health problem in Vietnam and other resource-constrained countries. All supplementation regimens could have clinically significant benefits for Hb and reduce anaemia risk among six-month-old infants. Universal provision of free intermittent iron supplements is warranted.

Project description:BackgroundAnaemia in pregnancy is highly prevalent in African countries. High-dose oral iron is the current recommended treatment for pregnancy-related iron deficiency anaemia (IDA) in Nigeria and other African countries. This oral regimen is often poorly tolerated and has several side effects. Parenteral iron preparations are now available for the treatment of IDA in pregnancy but not widely used in Africa. The IVON trial is investigating the comparative effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate standard-of-care for pregnancy-related IDA in Nigeria. We will also measure the implementation outcomes of acceptability, feasibility, fidelity, and cost-effectiveness for intravenous ferric carboxymaltose.MethodsThis is an open-label randomised controlled trial with a hybrid type 1 effectiveness-implementation design, conducted at 10 health facilities in Kano (Northern) and Lagos (Southern) states in Nigeria. A total of 1056 pregnant women at 20-32 weeks' gestational age with moderate or severe anaemia (Hb < 10g/dl) will be randomised 1:1 into two groups. The interventional treatment is one 1000-mg dose of intravenous ferric carboxymaltose at enrolment; the control treatment is thrice daily oral ferrous sulphate (195 mg elemental iron daily), from enrolment till 6 weeks postpartum. Primary outcome measures are (1) the prevalence of maternal anaemia at 36 weeks and (2) infant preterm birth (<37 weeks' gestation) and will be analysed by intention-to-treat. Maternal full blood count and iron panel will be assayed at 4 weeks post-enrolment, 36 weeks' gestation, delivery, and 6 weeks postpartum. Implementation outcomes of acceptability, feasibility, fidelity, and cost will be assessed with structured questionnaires, key informant interviews, and focus group discussions.DiscussionThe IVON trial could provide both effectiveness and implementation evidence to guide policy for integration and uptake of intravenous iron for treating anaemia in pregnancy in Nigeria and similar resource-limited, high-burden settings. If found effective, further studies exploring different intravenous iron doses are planned.Trial registrationISRCTN registry ISRCTN63484804 . Registered on 10 December 2020 Clinicaltrials.gov NCT04976179 . Registered on 26 July 2021 The current protocol version is version 2.1 (080/080/2021).

Project description:BackgroundIron Deficiency Anaemia (IDA) is reportedly high in pregnant adults and the causes well studied. However, among pregnant teenagers, the levels and associated factors of IDA are not fully understood.MethodsIn a prospective cohort study among Ghanaian pregnant teenagers, aged 13-19 years, IDA prevalence and associated factors were investigated. Sociodemographic data, household hunger scale (HHS), lived poverty index (LPI), FAO's women's dietary diversity score (WDDS) and interventions received during antenatal care (ANC) were obtained from 416 pregnant teenagers in Ashanti Region, Ghana. Micronutrient intakes using a repeated 24-hour dietary recall, and mid-upper arm circumference (MUAC) were determined and blood samples analysed for haemoglobin (Hb), serum levels of ferritin, prealbumin, vitamin A, total antioxidant capacity (TAC), C-reactive protein (CRP), and zinc protoporphyrin (ZPP).ResultsAnaemia (Hb cutoff <11.0 g/dL) was 57.1%; deficient systemic supply of iron stores (31.4%), depleted body stores of iron (4.4%), inadequate dietary iron intake (94.5%), and inadequate multiple micronutrient intakes (49.5%), were all notable among study participants. Between-subject effects using Generalized Linear Modelling indicated malaria tablet given at ANC (p = 0.035), MUAC (p = 0.043), ZPP (p<0.001), ZPP/Hb ratio (p<0.001) and depleted body iron stores (DBIS) (p<0.001) to significantly affect Hb levels. Pregnant teenagers with a high ZPP/Hb ratio (OR = 9.7, p<0.001, 95%CI = 6.0-15.8) had increased odds of being anaemic compared to those with normal ZPP/Hb ratio. Participants who were wasted (OR = 1.2, p = 0.543, 95%CI = 0.6-2.3), and those with depleted iron stores (OR = 3.0, p = 0.167, 95%CI = 0.6-14.6) had increased odds of being anaemic. Participants who experienced hunger were close to 3 times more likely (OR = 2.9, p = 0.040, 95%CI = 1.1-7.8) for depleted iron stores, compared to those who did not experience hunger. Also, participants with inadequate multiple micronutrients intakes (OR = 2.6, p = 0.102, 95%CI = 0.8-8.4), and those with low serum levels of ferritin (OR = 3.3, p = 0.291, 95%CI = 0.4-29.2) had increased odds of depleted body iron stores.ConclusionsIDA is common among pregnant teenagers and the related factors include malaria tablets given at ANC, maternal hunger, maternal MUAC, a deficient systemic supply of iron, depleted body iron stores, ZPP, and ZPP/Hb ratio. Appropriate interventions are urgently needed to address the causes of IDA among pregnant teenagers.

Project description:OBJECTIVE:To conduct a systematic review to investigate the safety of induction and/or augmentation of labour compared with spontaneous-onset normal labour among pregnant women with iron-deficiency anaemia. DESIGN:Systematic review. SETTING:Studies from all countries, worldwide. POPULATION:Pregnant women with iron-deficiency anaemia at labour and delivery. INTERVENTION:Any intervention related to induction and/or augmentation of labour. OUTCOME MEASURES:Primary: Postpartum haemorrhage (PPH), heart failure and maternal death. Secondary: Emergency caesarean section, hysterectomy, admission to intensive care unit. METHOD:We searched 10 databases, including Medline and Embase, from database inception to 1 October 2018. We included all study designs except cross-sectional studies without a comparator group, case reports, case series, ecological studies, and expert opinion. The searches were conducted by a healthcare librarian and two authors independently screened and reviewed the studies. We used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approachto ascertain risk of bias and conducted a narrative synthesis. RESULTS:We identified 3217 journal articles, 223 conference papers, 45 dissertations and 218 registered trials. Ten articles were included for full-text review and only one was found to fulfil the eligibility criteria. This was a retrospective cohort study from India, which showed that pregnant women with moderate and severe anaemia could have an increased risk of PPH if they underwent induction and/or augmentation of labour, but the evidence was weak (graded as 'high risk of bias'). CONCLUSION:The best approach is to prevent anaemia, but a large number of women in low-to-middle-income countries present with severe anaemia during labour. In such women, appropriate peripartum management could prevent complications and death. Our review showed that at present we do not know if induction and augmentation of labour is safe in pregnant women with iron-deficiency anaemia and further research is required. PROSPERO REGISTRATION NUMBER:CRD42015032421.

Dataset Information

Is untargeted iron supplementation harmful when iron deficiency is not the major cause of anaemia? Study protocol for a double-blind, randomised controlled trial among non-pregnant Cambodian women.

Publications

Is untargeted iron supplementation harmful when iron deficiency is not the major cause of anaemia? Study protocol for a double-blind, randomised controlled trial among non-pregnant Cambodian women.

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