Evidence map›Paper›PMID 29696163›Full record

ArticleContemporary clinical trials communications2017

Comparison of home fortification with two iron formulations among Kenyan children: Rationale and design of a placebo-controlled non-inferiority trial.

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

Open access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 30% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 4 countries.

Emily M TeshomeMRCG Keneba, MRC Unit The Gambia, Banjul, Gambia.
Walter OtienoMaseno University, School of Medicine, Maseno, Kenya.
Sofie R TerwelWageningen University, Cell Biology and Immunology Group, Division of Human Nutrition, Wageningen, The Netherlands.
Victor OsotiInternational Centre of Insect Physiology and Ecology, Nairobi, Kenya.
Ayşe Y DemirMeander Medical Centre, Laboratory for Clinical Chemistry, Amersfoort, The Netherlands.
Pauline E A AndangoMaseno University, School of Public Health and Community Development, Maseno, Kenya.
Andrew M PrenticeMRCG Keneba, MRC Unit The Gambia, Banjul, Gambia.
Hans VerhoefMRCG Keneba, MRC Unit The Gambia, Banjul, Gambia.
London School of Hygiene & Tropical Medicine · GBMaseno University · KEInternational Centre of Insect Physiology and Ecology · KEMeander Medisch Centrum · NLWageningen University & Research · NL

Funding

Medical Research Council MC_U123292699
6 · The paper itself

Abstract

introductionHome fortification powders containing iron and other micronutrients have been recommended by World Health Organisation to prevent iron deficiency anaemia in areas of high prevalence. There is evidence, however, that home fortification at this iron dose may cause gastrointestinal adverse events including diarrhoea. Providing a low dose of highly absorbable iron (3 mg iron as NaFeEDTA) may be safer because the decreased amount of iron in the gut lumen can possibly reduce the burden of these adverse effects whilst resulting in similar or higher amounts of absorbed iron.

objectiveTo show non-inferiority of home fortification with 3 mg iron as NaFeEDTA compared with 12.5 mg iron as encapsulated ferrous fumarate, with haemoglobin response as the primary outcome.

design338 Kenyan children aged 12-36 months will be randomly allocated to daily home fortification with either: a) 3 mg iron as NaFeEDTA (experimental treatment), b) 12.5 mg iron as encapsulated ferrous fumarate (reference), or c) placebo. At baseline, after 30 days of intervention and within 100 days post-intervention, blood samples will be assessed for primary outcome (haemoglobin concentration), iron status markers,

conclusionIf daily home fortification with a low dose of iron (3 mg NaFeEDTA) has similar or superior efficacy to a high dose (12.5 mg ferrous fumarate) then it would be the preferred choice for treatment of iron deficiency anaemia in children.

Indexed as

AdherenceAnaemiaChildDietary supplementsFortificationIronNon-inferiorityPreschool

Identifiers

PMID29696163
PMCPMC5898495
OpenAlexW2609113993

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.