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Session: Late Breaking/Rapid Science Oral Session

(LB01-06-24) IRon With MAlaria Chemoprevention on Child Development in Malawian Infants (IRMA): A Randomised Controlled Trial

Tuesday, July 2, 2024
8:00 AM – 8:12 AM CT
Location:  W183

    Presenting Author(s)

  • Sant-Rayn Pasricha, MBBS, PhD, MPH (he/him/his)

    Acting Deputy Director, Laboratory Head
    Walter and Eliza Hall Institute
    Parkville, Victoria, Australia

    Disclosure(s): CSL-Vifor: Advisory Committee/Board Member (Ongoing)
    ITL Biomedical: Consultant (Ongoing)
    Silence Therapeutics: Royalties or Patent Beneficiary (Ongoing)
    World Health Organization: Advisory Committee/Board Member (Ongoing); Consultant (Ongoing); Grant/Research Support (Ongoing)

    • Co-Author(s)

  • GM

    Glory Mzembe

    Training and Research Unit of Excellence, Malawi

  • RA

    Ricardo Ataide

    Walter and Eliza Hall Institute of Medical Research, Australia

  • MV

    Maclean Vokhiwa

    Training and Research Unit of Excellence, Malawi

  • MM

    Martin Mwangi

    Training and Research Unit of Excellence, United States

  • CN

    Chikondi Ngwira

    Training and Research Unit of Excellence, Malawi

  • MK

    Mayamiko Kapulula

    Training and Research Unit of Excellence, Malawi

  • AD

    Ayse Demir

    Meander Medical Center, Netherlands

  • Leila M. Larson, PhD

    Assistant Professor
    University of South Carolina, Arnold School of Public Health
    Columbia, South Carolina, United States

  • HV

    Hans` Verhoef

    Wageningen University, Netherlands

  • RH

    Rebecca Harding

    Walter and Eliza Hall Institute of Medical Research, Australia

  • JH

    Jena D. Hamadani, MD, PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh, icddrb
    Dhaka, Dhaka, Bangladesh

  • AM

    Alistair Maclean

    Walter and Eliza Hall Institute of Medical Research, Australia

  • SB

    Sabine Braat, MS

    University of Melbourne
    Melbourne, Victoria, Australia

  • KP

    Kamija Phiri

    Training and Research Unit of Excellence, Malawi

Objectives: WHO recommends universal iron supplements (eg syrup) or iron-containing Multiple Micronutrient Powders (MNPs) to all infants living where anaemia is prevalent, to alleviate negative functional effects on child development and health. However, evidence that iron benefits these outcomes is limited, and data from Africa are lacking. Conversely, iron may promote malaria. We aimed to define efficacy and safety of iron under malaria prophylaxis for infants in a sub-Saharan African setting.

Methods: IRMA was a four-arm, double-blind, triple-dummy placebo-controlled individually randomised controlled trial set in the malaria-endemic Chikwawa district of southern Malawi. Children were recruited at 6 months of age and randomised 1:1:1:1 to 6 months of a) placebo anti-malarials monthly + daily placebo syrup + daily placebo MNPs; b) Dihydroartermisinin-Piperaquine (active DP) monthly for 6 months + daily placebo syrup + daily placebo MNPs; c) active DP + daily iron syrup (10mg elemental iron) + daily placebo MNPs; or d) active DP + daily placebo syrup + daily MNPs (10mg elemental iron + 13 other micronutrients). The primary outcome was child cognitive development (Bayley Scales 3rd Ed.) immediately post-intervention, with a secondary timepoint 6 months following intervention.

Results: We recruited 2168 infants to the trial (70% anaemic [Hb < 11.0g/dL] at baseline); 1944 (89.7%) were assessed at the primary outcome timepoint. There was no difference in cognitive composite scores between children receiving DP and either iron syrup or MNPs and children receiving DP alone, either at the end of intervention or after a further six months follow up, nor was there a difference in children receiving DP alone compared to placebo, nor an effect from any intervention on language or motor development, or on length or weight. Compared to children receiving DP alone, haemoglobin and ferritin concentrations were higher in children receiving iron syrup or MNPs; elevations in ferritin (not haemoglobin) were sustained to 6-month post-follow up timepoint. DP did not change haemoglobin or ferritin. Malaria incidence was unaffected by iron.

Conclusions: In Malawian infants, iron syrup and MNPs raised haemoglobin and ferritin but did not benefit child development or other parameters of child health.

Funding Sources: National Health and Medical Research Council (Australia)