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

Mwangi, MN; Mzembe, G; Ngwira, CC; Vokhiwa, M; Kapulula, MD; Larson, LM; Braat, S; Harding, R; McLean, ARD; Hamadani, JD; Biggs, BA; Ata&#237;de, R; Phiri, KS; Pasricha, SR

Author(s): Mwangi, MN; Mzembe, G; Ngwira, CC; Vokhiwa, M; Kapulula, MD; Larson, LM; Braat, S; Harding, R; McLean, ARD; Hamadani, JD; Biggs, BA; Ataíde, R; Phiri, KS; Pasricha, SR;
Details: Publication Year 2023-10-13,Volume 13,Issue #10,Page e069011
Journal Title: BMJ Open
Abstract: INTRODUCTION: Approximately 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.
Publisher: BMJ
Keywords: Infant; Humans; Child; Iron/therapeutic use; Malawi/epidemiology; *Malaria/prevention & control/drug therapy; *Anemia/drug therapy; Dietary Supplements; Chemoprevention; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; Anaemia; Infection control; Nutrition; Public health
Research Division(s): Population Health And Immunity
PubMed ID: 37832986
Publisher's Version: https://doi.org/10.1136/bmjopen-2022-069011
Open Access at Publisher's Site: https://doi.org/10.1136/bmjopen-2022-069011
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-11-15 05:35:24

Last Modified: 2023-11-17 10:59:56