Evidence map›Paper›PMID 28449690›Full record

Trial reportBMC medicine2017

Daily home fortification with iron as ferrous fumarate versus NaFeEDTA: a randomised, placebo-controlled, non-inferiority trial in Kenyan children.

Emily M Teshome, Pauline E A Andang'o, Victor Osoti, Sofie R Terwel, Walter Otieno, Ayşe Y Demir, Andrew M Prentice, Hans Verhoef

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02073149 (Comparison of Home Fortification With Two Iron Formulations in Kenyan Children Protected Against Malaria by Artemisinin-based Combination Therapy), which is not on this map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02073149 phase2 / phase3completednot on this map

Comparison of Home Fortification With Two Iron Formulations in Kenyan Children Protected Against Malaria by Artemisinin-based Combination Therapy: a Placebo-controlled Non-inferiority Trial

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2014 to 2014Enrolled338ConditionsAnaemiaArmsLow-dose iron as NaFeEDTA, Conventional dose iron as ferrous salt, Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 24 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 4 countries.

Emily M TeshomeMRCG Keneba at MRC Unit, Banjul, The Gambia. Emily.teshome@lshtm.ac.uk.
Pauline E A Andang'oMaseno University, School of Public Health and Community Development, Maseno, Kenya.
Victor OsotiInternational Centre of Insect Physiology and Ecology, Nairobi, Kenya.
Sofie R TerwelDivision of Human Nutrition and Cell Biology and Immunology Group, Wageningen University, Wageningen, The Netherlands.
Walter OtienoMaseno University, School of Medicine, Maseno, Kenya.
Ayşe Y DemirMeander Medical Centre, Laboratory for Clinical Chemistry and Haematology, Amersfoort, The Netherlands.
Andrew M PrenticeMRCG Keneba at MRC Unit, Banjul, The Gambia.
Hans VerhoefMRCG Keneba at MRC Unit, Banjul, The Gambia.
Maseno University · KEWageningen University & Research · NLInternational Centre of Insect Physiology and Ecology · KELondon School of Hygiene & Tropical Medicine · GBMeander Medisch Centrum · NLMRC Unit the Gambia · GM

Funding

Medical Research Council MC_U123292699
6 · The paper itself

Abstract

backgroundWe aimed to show the non-inferiority of home fortification with a daily dose of 3 mg iron in the form of iron as ferric sodium ethylenediaminetetraacetate (NaFeEDTA) compared with 12.5 mg iron as encapsulated ferrous fumarate in Kenyan children aged 12-36 months. In addition, we updated a recent meta-analysis to assess the efficacy of home fortification with iron-containing powders, with a view to examining diversity in trial results.

methodsWe gave chemoprevention by dihydroartemisinin-piperaquine, albendazole and praziquantel to 338 afebrile children with haemoglobin concentration ≥70 g/L. We randomly allocated them to daily home fortification for 30 days with either placebo, 3 mg iron as NaFeEDTA or 12.5 mg iron as encapsulated ferrous fumarate. We assessed haemoglobin concentration (primary outcome), plasma iron markers, plasma inflammation markers and Plasmodium infection in samples collected at baseline and after 30 days of intervention. We conducted a meta-analysis of randomised controlled trials in pre-school children to assess the effect of home fortification with iron-containing powders on anaemia and haemoglobin concentration at end of intervention.

resultsA total of 315 children completed the 30-day intervention period. At baseline, 66.9% of children had inflammation (plasma C-reactive protein concentration >5 mg/L or plasma α

conclusionsIn this population, home fortification with either 3 mg iron as NaFeEDTA or 12.5 mg iron as encapsulated ferrous fumarate was insufficiently efficacious to assess non-inferiority of 3 mg iron as NaFeEDTA compared to 12.5 mg iron as encapsulated ferrous fumarate. Our finding of heterogeneity between trial results should stimulate subgroup analysis or meta-regression to identify population-specific factors that determine efficacy.

trial registrationThe trial was registered with ClinicalTrials.gov ( NCT02073149 ) on 25 February 2014.

Indexed as

Food, FortifiedAnemia, Iron-DeficiencyChild, PreschoolC-Reactive ProteinDouble-Blind MethodEdetic AcidFemaleFerric CompoundsFerritinsFerrous CompoundsHumansInfantIronKenyaMalariaMaleC-Reactive ProteinEdetic AcidFe(III)-EDTAFerric CompoundsFerritinsFerrous Compoundsferrous fumarateIronAnaemiaChildFerric sodium EDTAHome fortificationIronMeta-analysisNon-inferiorityPre-school

Identifiers

PMID28449690
PMCPMC5408380
OpenAlexW2605872288

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.