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TL;DR
This is a protocol for a randomized trial in Malawi to test if adding iron supplements or micronutrient powders to malaria prevention improves cognitive development in young children compared to malaria prevention alone or placebo.
BMJ Open · 14 authors, 10 centres
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This is a protocol for a randomized trial in Malawi to test if adding iron supplements or micronutrient powders to malaria prevention improves cognitive development in young children compared to malaria prevention alone or placebo.
This paper describes the protocol for the IRMA trial, a four-arm, double-blinded, placebo-controlled randomised trial in 2168 infants aged 6 months in Malawi. The trial compares four arms: placebo, malaria chemoprevention alone, micronutrient powders with malaria chemoprevention, and iron syrup with malaria chemoprevention over a 6-month intervention period and a 6-month post-intervention follow-up. The primary outcome is cognitive development (CogCS) measured at 6 months. Secondary outcomes include motor and language development, growth, anaemia, and iron deficiency. Safety outcomes include incidence of malaria, infections, and parasitaemia. The study aims to determine if iron added to malaria chemoprevention is superior to malaria chemoprevention alone or if malaria chemoprevention alone is superior to placebo on cognitive development. The large sample size and triple-dummy design are strengths, while limitations include routine 6-month malaria microscopy testing.