Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial

Edward J M Joy,R Murray Lark,E.l Ander ,Felix P Phiri,Patson C Nalivata,Martin R Broadley,John Phuka ,Elaine Ferguson ,Elizabeth H Bailey,Nicola M Lowe ,Dawd Gashu,Kate Millar,Limbanazo Matandika,Leonard Banda,Simon C Langley‐Evans ,Joanna Sturgess,Alexander Kalimbira ,Scott D Young,Gabriella Chiutsi‐Phiri ,Joseph Mfutso-Bengo,Jellita Gondwe,Alan D Dangour,Elizabeth Allen

doi:10.1186/s13063-019-3894-2

Abstract

BackgroundMicronutrient deficiencies including selenium (Se) are widespread in Malawi and potentially underlie a substantial disease burden, particularly among poorer and marginalised populations. Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers – a process known as agronomic biofortification (agro-biofortification) – and this may contribute to alleviating deficiencies. The Addressing Hidden Hunger with Agronomy (AHHA) trial aims to establish the efficacy of this approach for improving Se status in rural Malawi.MethodsA double-blind, randomised, controlled trial will be conducted in a rural community in Kasungu District, Central Region, Malawi. The hypothesis is that consumption of maize flour agro-biofortified with Se will increase serum Se concentration. We will recruit 180 women of reproductive age (WRA) (20–45 years) and 180 school-age children (SAC) (5–10 years) randomly assigned in a 1:1 ratio to receive either maize flour enriched through agro-biofortification with Se or a control flour not enriched with Se. Households will receive flour (330 g per capita per day) for 12 weeks. The primary outcome is Se concentration in serum (μg/L). Serum will be extracted from venous blood samples drawn at baseline (prior to flour distribution) and end-line. Selenium concentration will be measured by using inductively coupled plasma mass spectrometry.DiscussionFindings will be communicated to policy stakeholders and participating communities and reported in peer-reviewed journals.Trial registrationThe Addressing Hidden Hunger with Agronomy (Malawi) trial is registered (5th March 2019; ISCRTN85899451).

Highlights

Micronutrient deficiencies including selenium (Se) are widespread in Malawi and potentially underlie a substantial disease burden, among poorer and marginalised populations
Deficiency of Se occurs because of inadequate dietary Se intakes and this is driven by low concentrations of plant-available Se in the weathered agricultural soils that are typical of Malawi [5,6,7]
The concentration of bioavailable Se can be increased in the edible portion of staple crops – a process known as biofortification

Summary

Introduction

Micronutrient deficiencies including selenium (Se) are widespread in Malawi and potentially underlie a substantial disease burden, among poorer and marginalised populations. Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers – a process known as agronomic biofortification (agro-biofortification) – and this may contribute to alleviating deficiencies. There are various potential strategies – including dietary diversification, food fortification at processing stage, and supplementation – to alleviate Se deficiencies. The concentration of bioavailable Se can be increased in the edible portion of staple crops – a process known as biofortification. Agro-biofortification of maize can increase concentrations of Se in grain and may be a cost-effective and equitable strategy in Malawi, where maize contributes 60% of dietary energy supply and more among poorer populations [5, 7]

Objectives

Methods

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Conclusion