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

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


Edward J.M. Joy

Alexander A. Kalimbira

Dawd Gashu

Elaine L. Ferguson

Joanna Sturgess

Alan D. Dangour

Leonard Banda

Gabriella Chiutsi-Phiri

Associate Professor

R. Murray Lark

Professor of Applied Bioethics

Scott D. Young

Limbanazo Matandika

Joseph Mfutso-Bengo

John C. Phuka

Felix P. Phiri

Jellita Gondwe

Principal Research Fellow

Nicola M. Lowe

Patson C. Nalivata

Elizabeth Allen


© 2019 The Author(s). Background: Micronutrient 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. Methods: A 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. Discussion: Findings will be communicated to policy stakeholders and participating communities and reported in peer-reviewed journals. Trial registration: The Addressing Hidden Hunger with Agronomy (Malawi) trial is registered (5th March 2019; ISCRTN85899451).


Joy, E. J., Kalimbira, A. A., Gashu, D., Ferguson, E. L., Sturgess, J., Dangour, A. D., …Allen, E. (2019). Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial. Trials, 20(1), Article 795.

Journal Article Type Article
Acceptance Date Nov 8, 2019
Online Publication Date Dec 30, 2019
Publication Date Dec 30, 2019
Deposit Date Apr 25, 2021
Publicly Available Date Apr 26, 2021
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 20
Issue 1
Article Number 795
Public URL
Publisher URL


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