Evidence map›Paper›PMID 37832986›Full record

ArticleBMJ open2023

Protocol 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.

Martin N Mwangi, Glory Mzembe, Chikondi C Ngwira, Maclean Vokhiwa, Mayamiko D Kapulula, Leila M Larson, Sabine Braat, Rebecca Harding, Alistair R D McLean, Jena D Hamadani and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact, top 81% 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

3 citing papers in PubMed, 0 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

14 authors at 8 institutions in 4 countries.

Martin N MwangiTraining and Research Unit of Excellence (TRUE), Blantyre, Malawi mmwangi@true.mw.
Glory MzembeTraining and Research Unit of Excellence (TRUE), Blantyre, Malawi.ORCID 0000-0002-7277-9987
Chikondi C NgwiraTraining and Research Unit of Excellence (TRUE), Blantyre, Malawi.
Maclean VokhiwaTraining and Research Unit of Excellence (TRUE), Blantyre, Malawi.
Mayamiko D KapululaTraining and Research Unit of Excellence (TRUE), Blantyre, Malawi.
Leila M LarsonDepartment of Health Promotion, Education, and Behaviour, University of South Carolina Arnold School of Public Health, Columbia, South Carolina, USA.
Sabine BraatDepartment of Infectious Diseases at the Peter Doherty Institute of Infection and Immunity, The University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0003-1997-3999
Rebecca HardingPopulation Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia.ORCID 0000-0003-4267-716X
Alistair R D McLeanCentre for Epidemiology and Biostatistics, University of Melbourne School of Population and Global Health, Carlton, Victoria, Australia.ORCID 0000-0003-3449-7142
Jena D HamadaniInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Beverley-Ann BiggsDepartment of Infectious Diseases at the Peter Doherty Institute of Infection and Immunity, The University of Melbourne, Melbourne, Victoria, Australia.
Ricardo AtaídeDepartment of Infectious Diseases at the Peter Doherty Institute of Infection and Immunity, The University of Melbourne, Melbourne, Victoria, Australia.
Kamija S PhiriTraining and Research Unit of Excellence (TRUE), Blantyre, Malawi.
Sant-Rayn PasrichaPopulation Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia.
Kamuzu Central Hospital · MWThe University of Melbourne · AUBlantyre Institute for Community Ophthalmology · MWThe Royal Melbourne Hospital · AUInternational Centre for Diarrhoeal Disease Research · BDMicron (United States) · USUniversity of South Carolina · USWalter and Eliza Hall Institute of Medical Research · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionApproximately 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.

Indexed as

AnemiaMalariaChemopreventionChildDietary SupplementsHumansInfantIronMalawiMulticenter Studies as TopicRandomized Controlled Trials as TopicIronAnaemiaInfection controlNutritionPUBLIC HEALTH

Identifiers

PMID37832986
PMCPMC10583080
OpenAlexW4387618742

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.