scholarly journals 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

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e037232
Author(s):  
Jordie AJ Fischer ◽  
Lulu X Pei ◽  
David M Goldfarb ◽  
Arianne Albert ◽  
Rajavel Elango ◽  
...  
Keyword(s):  
British Columbia ◽  
Iron Deficiency ◽  
Research Ethics ◽  
Iron Supplementation ◽  
Double Blind ◽  
Ferritin Concentration ◽  
Potential Harm ◽  
Research Ethics Board ◽  
Randomised Controlled ◽  
Forms Of Iron

IntroductionThe 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 analysisA 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 disseminationEthical 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 numberClinicalTrials.gov Registry (NCT04017598).

scholarly journals Effects of iron intake on neurobehavioural outcomes in African children: a systematic review and meta-analysis of randomised controlled trials

2021 ◽  
Vol 6 ◽  
pp. 181
Author(s):  
Agnes M. Mutua ◽  
Kelvinson Mwangi ◽  
Amina Abubakar ◽  
Sarah H. Atkinson
Keyword(s):  
Systematic Review ◽  
Iron Deficiency ◽  
Developmental Delay ◽  
Randomised Controlled Trials ◽  
Iron Supplementation ◽  
Controlled Trials ◽  
African Countries ◽  
Beneficial Effects ◽  
African Children ◽  
Randomised Controlled

Background: Iron deficiency and developmental delay are common in African children. While experimental studies indicate an important role of iron in brain development, effects of iron on child development remain unclear. We aimed to evaluate the effects of iron supplementation or fortification on neurobehavioural outcomes in African children and further summarise these effects in children living in non-African countries for comparison. Methods: We searched PubMed, EMBASE, PsycINFO, Scopus and Cochrane Library for studies published up to 22nd October 2021. We included randomised controlled trials (RCTs) evaluating effects of iron supplementation or fortification on neurobehavioural outcomes in children. Due to heterogeneity in study methods, we analysed all studies qualitatively and in secondary analyses only seven RCTs with 11 arms were meta-analysed. Results: We identified 2231 studies and included 35 studies (n=9988) in the systematic review. Only five studies (n=1294) included African children while 30 (n=8694) included children living in non-African countries. Of the five African studies, two (n=647) reported beneficial effects of iron supplementation on neurobehavioural outcomes in anaemic children, while three (n=647) found no beneficial effects. Of 30 studies in children living in non-African countries, 10 (n=3105) reported beneficial effects of iron supplementation or fortification on neurobehavioural outcomes, seven (n=786) reported beneficial effects only in children who had iron deficiency, iron deficiency anaemia or anaemia while 13 (n=4803) reported no beneficial effects. Conclusions: There are few studies in African children despite the high burden of iron deficiency and developmental delay in this population. Evidence on the effects of iron supplementation on neurobehavioural outcomes remains unclear and there is need for further well-powered studies evaluating these effects in African populations. PROSPERO registration: CRD42018091278 (20/03/2018)

scholarly journals Effects of iron intake on neurobehavioural outcomes in African children: a systematic review and meta-analysis of randomised controlled trials

2021 ◽  
Vol 6 ◽  
pp. 181
Author(s):  
Agnes M. Mutua ◽  
Kelvinson Mwangi ◽  
Amina Abubakar ◽  
Sarah H. Atkinson
Keyword(s):  
Systematic Review ◽  
Iron Deficiency ◽  
Randomised Controlled Trials ◽  
Iron Supplementation ◽  
Meta Analysis ◽  
Controlled Trials ◽  
African Countries ◽  
Beneficial Effects ◽  
African Children ◽  
Randomised Controlled

Background: Iron deficiency and developmental delay are common in African children. While experimental studies indicate an important role of iron in brain development, effects of iron on child development remain unclear. We aimed to evaluate the effects of iron supplementation or fortification on neurobehavioural outcomes in African children and further summarise these effects in children living in non-African countries for comparison. Methods: We searched PubMed, EMBASE, PsycINFO, Scopus and Cochrane Library for studies published up to 9th March 2021. We included randomised controlled trials (RCTs) evaluating effects of iron supplementation or fortification on neurobehavioural outcomes in children. Due to heterogeneity in study methods, we analysed the studies qualitatively and only seven RCTs with 11 arms were meta-analysed. Results: We identified 2155 studies and included 34 studies (n=9808) in the systematic review. Only five studies (n=1294) included African children while 29 (n=8514) included children living in non-African countries. Of the five African studies, two (n=647) reported beneficial effects of iron supplementation on neurobehavioural outcomes in anaemic children while three (n=647) found no beneficial effects. Of 29 studies in children living in non-African countries, nine (n=2925) reported beneficial effects of iron supplementation or fortification on neurobehavioural outcomes, seven (n=786) reported beneficial effects only in children who had iron deficiency, iron deficiency anaemia or anaemia while 13 (n=4803) reported no beneficial effects. Meta-analysis of seven studies (n=775) in non-African countries showed no beneficial effects of iron supplementation on cognitive or motor development in children. Conclusions: There are few studies in African children despite the high burden of iron deficiency and developmental delay in this population. Evidence on the effects of iron supplementation on neurobehavioural outcomes remains unclear and there is need for further well-powered studies evaluating these effects in African populations. PROSPERO registration: CRD42018091278 (20/03/2018)

scholarly journals Safe and effective delivery of supplemental iron to healthy older adults: The double-blind, randomized, placebo-controlled trial protocol of the Safe Iron Study

2019 ◽  
Vol 3 ◽  
pp. 1510
Author(s):  
Erin D. Lewis ◽  
Dayong Wu ◽  
Joel B. Mason ◽  
Athar H. Chishti ◽  
John M. Leong ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Adverse Effects ◽  
Phase I ◽  
Ex Vivo ◽  
Iron Status ◽  
Controlled Trial ◽  
Double Blind ◽  
Sulfate Heptahydrate ◽  
Bacterial Proliferation ◽  
Forms Of Iron

The forms of iron currently available to correct iron deficiency have adverse effects, including infectious diarrhea, increased susceptibility to malaria, inflammation and detrimental changes to the gut microbiome. These adverse effects limit their use such that the growing burden of iron deficiency has not abated in recent decades. Here, we summarize the protocol of the “Safe Iron Study”, the first clinical study examining the safety and efficacy of novel forms of iron in healthy, iron-replete adults. The Safe Iron Study is a double-blind, randomized, placebo-controlled trial conducted in Boston, MA, USA. This study compares ferrous sulfate heptahydrate (FeSO4·H2O) with two novel forms of iron supplements (iron hydroxide adipate tartrate (IHAT) and organic fungal iron metabolite (Aspiron™ Natural Koji Iron)). In Phase I, we will compare each source of iron administrated at a low dose (60 mg Fe/day). We will also determine the effect of FeSO4 co-administrated with a multiple micronutrient powder and weekly administration of FeSO4. The forms of iron found to produce no adverse effects or adverse effects no greater than FeSO4 in Phase I, Phase II will evaluate a higher, i.e., a therapeutic dose (120 mg Fe/day). The primary outcomes of this study include ex vivo malaria (Plasmodium falciparum) infectivity of host erythrocytes, ex vivo bacterial proliferation (of selected species) in presence of host plasma and intestinal inflammation assessed by fecal calprotectin. This study will test the hypotheses that the novel forms of iron, administered at equivalent doses to FeSO4, will produce similar increases in iron status in iron-replete subjects, yet lower increases in ex vivo malaria infectivity, ex vivo bacterial proliferation, gut inflammation. Ultimately, this study seeks to contribute to development of safe and effective forms of supplemental iron to address the global burden of iron deficiency and anemia. Registration: ClinicalTrials.gov identifier: NCT03212677; registered: 11 July 2017.

scholarly journals Micronized, Microencapsulated Ferric Iron Supplementation in the Form of >Your< Iron Syrup Improves Hemoglobin and Ferritin Levels in Iron-Deficient Children: Double-Blind, Randomized Clinical Study of Efficacy and Safety

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1087
Author(s):  
Aida Zečkanović ◽  
Marko Kavčič ◽  
Tomaž Prelog ◽  
Alenka Šmid ◽  
Janez Jazbec
Keyword(s):  
Iron Deficiency ◽  
Iron Supplementation ◽  
Ferric Iron ◽  
Hematological Parameters ◽  
Food Supplement ◽  
Healthy Children ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Randomized Clinical Study ◽  
Iron Deficient

A major problem of oral iron supplementation efficacy in children is its tolerability and compliance. We aimed to determine the safety and efficacy of a novel food supplement >Your< Iron Syrup in the replenishment of iron stores and improvement of hematological parameters in iron-deficient children aged nine months to six years. We randomized 94 healthy children with iron deficiency in a ratio of 3:1 to either receive >Your< Iron Syrup or placebo. A 12-week supplementation with >Your< Iron Syrup resulted in a significant increase in ferritin and hemoglobin levels as compared to placebo (p = 0.04 and p = 0.02). Adverse events were reported with similar frequencies across both study arms. >Your< Iron Syrup represents an effective, well-tolerated, and safe option for the management of nutritional iron deficiency in children.

scholarly journals Protocol for a randomised controlled trial for Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS)

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e052070
Author(s):  
Ming Hao Guo ◽  
Jehangir J Appoo ◽  
George A Wells ◽  
Michael Chu ◽  
Maral Ouzounian ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Aortic Aneurysm ◽  
Research Ethics ◽  
Thoracic Aortic Aneurysm ◽  
Controlled Trial ◽  
Health Science ◽  
Aneurysm Surgery ◽  
Research Ethics Board ◽  
Randomised Controlled ◽  
Aortic Aneurysm Surgery

IntroductionAscending thoracic aortic aneurysm (ATAA) is an asymptomatic condition that can lead to catastrophic events of rupture or dissection. Current guidelines are based on limited retrospective data and recommend surgical intervention for ATAA with a diameter of greater or equal to 5.5 cm. Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance is the first prospective, multicentre, randomised controlled trial that compares outcomes of patients undergoing early elective ascending aortic surgery to patients undergoing medical surveillance.Methods and analysisPatients between the ages of 18 and 80 with an asymptomatic ATAA between 5.0 cm and 5.4 cm in diameter are eligible for randomisation to early surgery or surveillance. Patients in the surgery group will be followed at 1 month after discharge, then annually for a minimum of 2 years and up to 5 years. Patients in the surveillance group will be followed annually from their index clinic visit for a minimum of 2 years and up to 5 years. The primary outcome is all-cause mortality at follow-up. A sample size of 618 subjects (309 in each group) will achieve an 80% power at a 0.047 significance level.Ethics and disseminationThis study has received Ottawa Health Science Network Research Ethics Board approval (Protocol 20180007-01H), which was most recently updated on 25 November 2020. The Research Ethics Board have granted approval to the study at 14 participating institutions, including the Ottawa Health Science Network Research Ethics Board. On completion of data analysis, the result of the trial will be presented at national and international conferences, and published in relevant journals, regardless of the finding of the trial.Trial registration numberNCT03536312.

scholarly journals Safe and effective delivery of supplemental iron to healthy older adults: The double-blind, randomized, placebo-controlled trial protocol of the Safe Iron Study

2021 ◽  
Vol 3 ◽  
pp. 1510
Author(s):  
Erin D. Lewis ◽  
Dayong Wu ◽  
Joel B. Mason ◽  
Athar H. Chishti ◽  
John M. Leong ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Adverse Effects ◽  
Phase I ◽  
Ex Vivo ◽  
Iron Status ◽  
Controlled Trial ◽  
Double Blind ◽  
Sulfate Heptahydrate ◽  
Bacterial Proliferation ◽  
Forms Of Iron

The forms of iron currently available to correct iron deficiency have adverse effects, including infectious diarrhea, increased susceptibility to malaria, inflammation and detrimental changes to the gut microbiome. These adverse effects limit their use such that the growing burden of iron deficiency has not abated in recent decades. Here, we summarize the protocol of the “Safe Iron Study”, the first clinical study examining the safety and efficacy of novel forms of iron in healthy, iron-replete adults. The Safe Iron Study is a double-blind, randomized, placebo-controlled trial conducted in Boston, MA, USA. This study compares ferrous sulfate heptahydrate (FeSO4·H2O) with two novel forms of iron supplements (iron hydroxide adipate tartrate (IHAT) and organic fungal iron metabolite (Aspiron™ Natural Koji Iron)). In Phase I, we will compare each source of iron administrated at a low dose (60 mg Fe/day). We will also determine the effect of FeSO4 co-administrated with a multiple micronutrient powder and weekly administration of FeSO4. The forms of iron found to produce no adverse effects, or adverse effects no greater than FeSO4 in Phase I, Phase II will evaluate a higher, i.e., a therapeutic dose (120 mg Fe/day). The primary outcomes of this study include ex vivo malaria (Plasmodium falciparum) infectivity of host erythrocytes, ex vivo bacterial proliferation (of selected species) in presence of host plasma and intestinal inflammation assessed by fecal calprotectin. This study will test the hypotheses that the novel forms of iron, administered at equivalent doses to FeSO4, will produce similar increases in iron status in iron-replete subjects, yet lower increases in ex vivo malaria infectivity, ex vivo bacterial proliferation, gut inflammation. Ultimately, this study seeks to contribute to development of safe and effective forms of supplemental iron to address the global burden of iron deficiency and anemia. Registration: ClinicalTrials.gov identifier: NCT03212677; registered: 11 July 2017.

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